使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主
Operator
Operator
Hello, and welcome to the Phathom Pharmaceuticals second-quarter 2025 earnings results call. (Operator Instructions) Please be advised that today's call is being recorded.
您好,歡迎參加 Phathom Pharmaceuticals 2025 年第二季業績電話會議。 (操作員指示)請注意,今天的電話會議正在錄音中。
With that, I'd like to turn the call over to Eric Sciorilli, Phathom's Head of Investor Relations. Please go ahead.
接下來,我想把電話轉給 Phathom 投資者關係主管 Eric Sciorilli。請繼續。
Eric Sciorilli - Director, Business Development & Investor Relations
Eric Sciorilli - Director, Business Development & Investor Relations
Thank you, operator. Hello, everyone, and thank you for joining us this morning to discuss Phathom's second quarter 2025 results. This morning's presentation will include remarks from Steve Basta, our President and CEO; and Robert Breedlove, our VP of Finance and Principal Accounting Officer.
謝謝接線生。大家好,感謝您今天早上加入我們,共同討論Phathom 2025年第二季的業績。今天早上的演講將包括我們總裁兼執行長Steve Basta和財務副總裁兼首席會計長Robert Breedlove的致詞。
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 and the slides we'll be reviewing can be found under the Events and Presentations section of our corporate website.
在我們開始之前,還有幾件後勤事宜需要處理。今天早上,我們發布了一份新聞稿,詳細介紹了我們將在電話會議上討論的結果。這份新聞稿的副本可以在我們公司網站的「新聞稿」欄位下找到。此外,今天的網路直播錄音和我們將要審查的幻燈片可以在我們公司網站的「活動和簡報」欄位下找到。
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.
在開始之前,請允許我提醒您,今天的演示中我們將做出一些前瞻性陳述。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。
Actual results may materially differ from the forward-looking statements, and any such risks may materially adversely affect our business and results of operations and the trading prices of Phathom's common stock.
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我們的業務和經營業績以及 Phathom 普通股的交易價格產生重大不利影響。
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.
有關這些聲明和風險因素的討論,請參閱目前的安全港投影片以及我們最新的10-K表格和後續SEC文件中的「風險因素」部分。本次電話會議中的所有前瞻性陳述均基於Phathom截至當日的信念,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,我會把電話交給 Phathom 總裁兼執行長 Steve Basta,由他來主持會議。史蒂夫?
Steven Basta - President, Chief Executive Officer, Director
Steven Basta - President, Chief Executive Officer, Director
Thank you, Eric, and thank you to everyone joining us on the call today. I'm pleased to share our second quarter results, which reflect the first step in our mission to build a growth-oriented and profitable GI company. We believe this quarter marks a meaningful inflection point for Phathom.
謝謝艾瑞克,也謝謝今天參加電話會議的各位。我很高興分享我們第二季的業績,這體現了我們打造一家以成長為導向、獲利能力強的GI公司這一使命的第一步。我們相信,本季將是Phathom一個意義重大的轉捩點。
Let's begin with the key performance metrics. Launch through July 25, over 580,000 VOQUEZNA prescriptions have been filled, 49% growth in 14 weeks since our last report. In Q2, approximately 173,000 prescriptions were filled, reflecting 36% growth over Q1.
我們先來看看關鍵績效指標。截至7月25日,VOQUEZNA已配藥超過58萬份,自我們上次報告發布以來的14週內成長了49%。第二季度,配藥約17.3萬份,較第一季成長36%。
Commercial access remains north of 80% of lives covered with more than half of those requiring only a single step edit or less. BlinkRx continues to be a resource for both patients with coverage and for patients denied coverage who are then offered a cash pay option.
商業通路覆蓋率仍維持在80%以上,其中超過一半的患者只需單步或更少的編輯即可。 BlinkRx 將繼續為受保患者和被拒絕的患者提供資源,後者可獲得現金支付選項。
Approximately 68% of Q2 VOQUEZNA prescriptions were filled through the retail channel. This slight decrease in retail proportionality this quarter is due to the rollout of a cash pay option for Medicare patients through BlinkRx. This has brought in incremental new patients and helps to instill confidence among HCPs as more patients have positive access experiences.
第二季度,約68%的VOQUEZNA處方是透過零售通路配藥的。本季零售比例略有下降,原因是BlinkRx為Medicare患者推出了現金支付選項。這帶來了新增患者,並有助於增強醫護人員的信心,因為越來越多的患者獲得了積極的就醫體驗。
Importantly, both covered and cash pay segments are growing at healthy rates. Through July 18, more than 29,300 unique HCPs have written a filled VOQUEZNA script, approximately 24% more than at the time of our Q1 report. Although we expect the number of total writers to continue growing, our focus beginning in Q3 of this year has shifted to driving more depth and frequency of writing more than to driving new writer conversions.
重要的是,保險付費和現金付費部分都在健康成長。截至7月18日,已有超過29,300名獨立醫療專業人士撰寫了VOQUEZNA的劇本,比我們第一季報告發佈時增長了約24%。雖然我們預期總寫手數量將持續成長,但從今年第三季開始,我們的重點已轉向提升寫作的深度和頻率,而非推動新寫手的轉換。
We recently refreshed our sales force target list to prioritize gastroenterologists. Of note, about 70% of all VOQUEZNA prescriptions written to date have come from GIs. Even though we've actually been spending more than 60% of our sales time in the last 12 months on primary care physician calls, we are clearly seeing, therefore, a higher return from our sales calls on GIs.
我們最近更新了銷售人員目標清單,優先考慮胃腸病專家。值得注意的是,迄今為止,VOQUEZNA 處方中約有 70% 來自胃腸病專家。儘管過去 12 個月,我們實際上有超過 60% 的銷售時間花在了初級保健醫生的拜訪上,但我們清楚地看到,胃腸病專家的拜訪帶來了更高的回報。
Likely, this is because a greater percentage of PPI patients treated by GI still experience GERD symptoms and need a new treatment option. In Q2, gastroenterology writers on average, wrote more than twice the prescriptions per month as compared to primary care physician writers, which illustrates that our GI sales calls are more productive than our PCP sales calls.
這很可能是因為在接受胃腸科 (GI) 治療的PPI患者中,仍有較大比例的患者出現胃食道逆流症 (GERD) 症狀,需要新的治療方案。第二季度,胃腸科醫師開立處方量平均每月是初級保健醫師開立處方量的兩倍多,這表明我們的胃腸科銷售拜訪比PCP銷售拜訪更有效率。
We believe that more time spent driving GI adoption will translate to accelerated revenue growth. Starting in July, our new sales target list now includes nearly all gastroenterologists. We've removed from the target list more than 20,000 PCP targets who had not yet started writing.
我們相信,投入更多時間推動胃腸道疾病的普及將轉化為收入的加速成長。從7月開始,我們新的銷售目標名單幾乎涵蓋了所有胃腸病學家。我們已從目標名單中剔除2萬多名尚未開始撰寫處方的PCP目標醫師。
The net effect of now including all gastroenterologists and removing of unproductive PCP targets is to free up our reps' time to focus on GIs and to increase call frequency with these high potential writers. This is a deliberate move to drive depth over breadth and to move prescribers up the adoption ladder from trialists to consistent writers to daily adopters.
現在,所有胃腸病專家都參與其中,並取消了效率低下的PCP目標,最終的效果是,我們的銷售代表可以騰出更多時間專注於胃腸病患者,並提高與這些高潛力寫藥師的通話頻率。此舉旨在提升深度而非廣度,並幫助處方人員從試用者提升到持續寫藥師,再到每日寫藥師。
In making these changes, we are not discounting the significant future opportunity that exists with PCPs. Rather, we anticipate phased growth. Step one, GIs are the core writers with high awareness of VOQUEZNA today, delivering a greater return per sales call.
在進行這些改變的過程中,我們並沒有低估PCP未來蘊藏的巨大機會。相反,我們預期的是分階段的成長。第一步,GI是目前對VOQUEZNA認知度較高的核心寫手,能夠帶來更高的單次銷售回報。
Focusing on GIs is a clear and efficient path to our goal of growth and profitability. In time, primary care physicians will hear from their GERD patients how much better they feel on VOQUEZNA as they return from GI referrals.
專注於胃腸道疾病是我們實現成長和獲利目標的清晰而有效的途徑。假以時日,初級保健醫生將會聽到胃食道逆流症 (GERD) 患者在胃腸道轉診後,服用 VOQUEZNA 後感覺好多了。
We believe that our reps will then be able to more efficiently convert and grow PCP adoption. We expect transitioning sales targets will take time to show benefit in our sales ramp. It takes several calls over months to move the needle with new physicians. I expect that we may start to see an acceleration of revenue within the next three to three quarters as we are able to call on GIs multiple times, leading to greater writing frequency in our core customer segment.
我們相信,我們的銷售代表將能夠更有效率地轉換並提升PCP(個人護理醫生)的採用率。我們預計,轉變銷售目標需要一段時間才能在銷售成長中體現效益。需要幾個月的時間進行多次拜訪才能吸引新醫生。我預計,隨著我們能夠多次拜訪醫生,從而提高我們核心客戶群的寫信頻率,我們可能會在未來三到三個季度內開始看到收入成長加速。
Two notes on our reported metrics may be helpful. First, as we spend more time with existing customers to go deeper, our rate of converting new writers in future quarters will not be as high a priority. We may elect, therefore, to report different metrics in the future rather than writer counts due to this change in focus.
關於我們報告的指標,有兩點需要注意。首先,隨著我們投入更多時間與現有客戶進行更深入的溝通,未來幾季新寫手的轉換率將不再是我們優先考慮的因素。因此,鑑於這一關注點的變化,我們未來可能會選擇報告其他指標,而不是寫手數量。
Second, regarding the prescription numbers we've reported, IQVIA has implemented two recent restatements. All weekly Rx data from launch through July 4 have been revised. The launch to date and Q2 TRx numbers that we are reporting today, therefore, incorporate IQVIA's weekly restatements and some internal estimates of monthly data. The restatements have no impact on our actual revenues, which are not derived from the IQVIA numbers.
其次,關於我們報告的處方數據,IQVIA 最近進行了兩次重述。從產品上市到 7 月 4 日的所有每週處方資料均已修訂。因此,我們今天報告的上市至今和第二季的處方數據均包含了 IQVIA 的每週重述和一些內部估算的月度數據。這些重述對我們的實際收入沒有影響,因為我們的實際收入並非來自 IQVIA 的數據。
Turning for a moment to exclusivity. We were pleased that we achieved a positive resolution to our citizens petition in early June. The FDA has now officially updated the Orange Book to reflect exclusivity for the VOQUEZNA 10 milligram and 20 milligram tablets through May of 2032.
暫時談談獨家經營權。我們很高興在六月初就公民請願書獲得了積極的解決方案。 FDA 現已正式更新橙皮書,以反映 VOQUEZNA 10 毫克和 20 毫克片劑的獨家經營權有效期至 2032 年 5 月。
It's important to clarify regarding timeline that this date of May 2032 marks the earliest point at which a generic ANDA can be filed, assuming that we do not have an Orange Book listed patent one year prior to that date. Therefore, we believe that the actual entry point of a generic vonoprazan competitor should be no earlier than 2033, assuming a typical ANDA review cycle.
關於時間線,需要澄清的是,假設我們在該日期前一年沒有橙皮書專利,那麼2032年5月是可以提交仿製藥ANDA的最早日期。因此,我們認為,按照典型的ANDA審查週期,沃諾拉贊仿製藥競爭對手的實際進入時間應該不早於2033年。
Pediatric exclusivity, potential future IP and multiple rounds of ANDA review for generic filers could potentially extend our exclusivity window even further. Confirming exclusivity into 2033 clearly enhances the NPV of VOQUEZNA.
兒童獨佔權、未來潛在的智慧財產權以及仿製藥申請人的多輪ANDA審查,可能會進一步延長我們的獨佔期。確認獨佔期持續至2033年,無疑將提升VOQUEZNA的淨現值。
Following the Citizens petition decision, we have also revisited our development plans and near-term priority clinical studies. We've recently decided to move forward with a Phase 2 trial in eosinophilic esophagitis or EoE, which we expect to begin Q4 of this year.
根據公民請願書的決定,我們也重新審視了我們的開發計劃和近期優先臨床研究。我們最近決定推進嗜酸性細胞食道炎(EoE)的第二期臨床試驗,預計今年第四季開始。
We believe VOQUEZNA has the potential to be a first-line treatment in this indication for which PPIs are commonly used today despite not being indicated for EoE. Additionally, the EoE program may provide a path to extend exclusivity by six months with future pediatric evaluation in this indication.
我們相信,VOQUEZNA 有潛力成為此適應症的第一線治療藥物,儘管目前PPIs仍被廣泛用於治療EoE,但該適應症尚未被批准用於治療EoE。此外,EoE計畫可能提供一條途徑,在未來進行兒科評估後,將獨佔期延長六個月。
Robert will provide more detailed financial update shortly. But first, I'll highlight some key recent financial progress. We reported $39.5 million in revenue for Q2, which represents 39% growth over Q1 revenue. We started to implement our cost savings initiatives mid-quarter in Q2 and have already shown a $12 million reduction in Q2 non-GAAP OpEx compared to Q1.
Robert 很快就會提供更詳細的財務更新。但首先,我將重點放在一些近期的關鍵財務進展。我們報告第二季度營收為 3,950 萬美元,較第一季成長 39%。我們在第二季中期開始實施成本節約計劃,並已顯示第二季度非 GAAP 營運支出較第一季減少了 1,200 萬美元。
We ended the quarter with approximately $150 million in cash. Based on our operating plan, with anticipated continued revenue growth and rigorous cost control efforts, we believe our current cash can be sufficient to reach profitability without requiring additional equity financing.
本季末,我們持有約1.5億美元現金。根據我們的營運計劃,在預期持續的收入成長和嚴格的成本控制措施的推動下,我們相信現有現金足以實現盈利,而無需額外的股權融資。
Analyst consensus revenue for 2025 currently sits at approximately $160 million. We expect that we can achieve revenue north of current analyst estimates and are providing revenue guidance of $165 million to $175 million for full year 2025.
目前,分析師對2025年營收的預期約為1.6億美元。我們預計2025年營收將高於分析師目前的預期,並預計2025年全年營收將達到1.65億美元至1.75億美元。
We're also on track with our expense reduction activities. We expect Q3 expenses to be below $60 million for the quarter and our Q4 expenses to be below $55 million, including the incremental costs associated with starting the EoE trial in Q4.
我們的費用削減計劃也進展順利。我們預計第三季的支出將低於6,000萬美元,第四季的支出將低於5,500萬美元,這包括第四季啟動EoE試點計畫所產生的增量成本。
Recall that this guidance is intended to reflect only cash operating expenses that excludes stock-based compensation and other noncash items. These expense reduction targets reflect our disciplined approach to spending while continuing to invest aggressively in key areas driving revenue growth.
需要注意的是,本指引僅反映現金營運支出,不包括股票薪酬及其他非現金項目。這些支出削減目標反映了我們嚴謹的支出策略,同時繼續在推動收入成長的關鍵領域進行積極投資。
As a final note, we communicated last quarter that there could be a supply disruption in the VOQUEZNA triple pack. The triple pack represents approximately 1% of our total revenue. The supply issue pertains specifically to the clarithromycin tablets in the triple pack.
最後要說明的是,我們在上個季度曾通報過,VOQUEZNA 三包裝可能有供應中斷的情況。這三包裝約占我們總收入的 1%。此次供應問題具體涉及三包裝中的克拉黴素片。
We are in ongoing discussions with our supplier for these tablets and continue to actively monitor this situation. We have not experienced any commercial disruption to date. The VOQUEZNA bottles and the VOQUEZNA dual packs are not impacted as they do not include clarithromycin. We are prepared to quickly shift our H. pylori marketing emphasis fully to the dual pack if needed.
我們正在與這些藥片的供應商進行持續溝通,並持續密切關注事態發展。迄今為止,我們尚未遇到任何商業中斷。 VOQUEZNA 瓶裝和 VOQUEZNA 雙包裝不受影響,因為它們不含克拉黴素。如有需要,我們準備迅速將針對幽門螺旋桿菌的行銷重點完全轉移到雙包裝上。
Q2 was a strong quarter for Phathom. We're executing on our strategy, delivering results and laying the foundation for long-term growth. We believe we're on track to reach profitability in 2026.
Phathom 在第二季表現強勁。我們正在執行策略,取得成果,並為長期成長奠定基礎。我們相信,我們預計在 2026 年將實現盈利。
Importantly, 30% to 40% of GERD patients still have symptoms while on PPIs or other common treatments. VOQUEZNA's rapid, potent and durable acid suppression profile provides a meaningful treatment option for these patients.
值得注意的是,30% 至 40% 的 GERD 患者在接受 PPI 或其他常見治療時仍有症狀。 VOQUEZNA 快速、強效且持久的抑酸特性為這些患者提供了有意義的治療選擇。
We received numerous testimonials about the benefits of VOQUEZNA and how it's providing significant improvement in care for patients with GERD. It's a privilege to be part of a team that is making a significant difference for many thousands of patients today and potentially millions more patients in the years to come.
我們收到了無數關於VOQUEZNA的益處以及它如何顯著改善GERD患者護理的評估。能夠加入這個團隊,我深感榮幸。這個團隊正在為目前成千上萬的患者帶來顯著的改變,並可能在未來惠及數百萬名患者。
I'll now turn the call over to Robert to walk through the financials in more detail.
現在我將把電話轉給羅伯特,讓他更詳細地介紹一下財務狀況。
Robert Breedlove - Vice President, Finance & Principal Accounting Officer
Robert Breedlove - Vice President, Finance & Principal Accounting Officer
Thanks, Steve, and hello, everyone. I appreciate you joining us today. We are pleased with our results for the quarter and the progress we have made both in terms of our revenue growth and cost savings.
謝謝,史蒂夫,大家好。感謝大家今天加入我們。我們對本季的業績以及在收入成長和成本節約方面取得的進展感到滿意。
This morning, I'll be walking through our financial results for the second quarter of 2025, and I'll be commenting on both GAAP and non-GAAP financial measures. As always, detailed reconciliations between our non-GAAP results and the most directly comparable GAAP measures are included in this morning's press release and will also be discussed later in my remarks.
今天上午,我將介紹我們2025年第二季的財務業績,並將對GAAP和非GAAP財務指標進行評論。像往常一樣,我們的非GAAP業績與最直接可比較的GAAP指標之間的詳細對帳已包含在今天上午的新聞稿中,我稍後也會在發言中討論。
As Steve mentioned, we reported net revenues of $39.5 million for Q2 2025, which represents a 39% increase compared to the prior quarter. This revenue growth was driven entirely by the increased adoption of VOQUEZNA, reflecting the success of our ongoing commercial efforts. As of quarter end, wholesaler inventory levels remain consistent with historical norms, averaging approximately two weeks of supply.
正如史蒂夫所提到的,我們報告稱,2025年第二季的淨收入為3,950萬美元,較上一季成長39%。這項營收成長完全得益於VOQUEZNA的普及,這反映了我們持續商業努力的成功。截至季末,批發商庫存水準與歷史水準保持一致,平均約為兩週的供應量。
Based on prescription trends and our revised sales strategy, we are providing full year 2025 revenue guidance of $165 million to $175 million. Our gross to net discount rate for the quarter was within our expected range of 55% to 65%, and we expect the discount rate to remain within this range for the remainder of 2025.
根據處方趨勢和我們修訂的銷售策略,我們預計2025年全年收入將達到1.65億美元至1.75億美元。本季的毛利/淨利折現率在我們預期的55%至65%範圍內,我們預計2025年剩餘時間的折現率將維持在此範圍內。
Now turning to operating expenses. For Q2, we reported non-GAAP research and development expenses of $7.4 million and non-GAAP selling, general and administrative expenses of $78.7 million. Compared to the same period in 2024, these represent increases of 23% and 11%, respectively.
現在談談營運費用。第二季度,我們報告的非公認會計準則研發費用為 740 萬美元,非公認會計準則銷售、一般及行政費用為 7,870 萬美元。與 2024 年同期相比,這兩項費用分別增加了 23% 和 11%。
This year-over-year increase in R&D was primarily due to one-time personnel-related restructuring charges, while the increase in SG&A reflects continued commercial investment in support of the VOQUEZNA launch. As part of our previously communicated cost-saving efforts, we achieved a meaningful reduction in spending this quarter compared to Q1 of 2025.
研發費用較去年成長主要源自於一次性人員重組相關費用,而銷售、一般及行政費用(SG&A)的成長則反映了為支持VOQUEZNA上市而進行的持續商業投資。作為我們先前已溝通的成本節約舉措的一部分,本季的支出與2025年第一季相比實現了顯著下降。
Total non-GAAP operating expenses for Q2 2025 were $86.1 million, which is a $12 million decrease from Q1 2025. This decrease was driven by $18 million in savings, partially offset by approximately $6 million in onetime restructuring-related costs.
2025 年第二季非 GAAP 營運費用總額為 8,610 萬美元,比 2025 年第一季減少 1,200 萬美元。這一減少是由於 1800 萬美元的節省,部分被約 600 萬美元的一次性重組相關成本所抵消。
We are encouraged by this early progress, and we anticipate more substantial reductions in the second half of the year. To give some context, our Q2 non-GAAP operating expenses included approximately $15 million in pre-committed direct-to-consumer advertising spend, $7 million in project costs that could not be discontinued before Q3 and the aforementioned $6 million in one-time restructuring charges.
我們對這項初步進展感到鼓舞,並預計下半年將出現更大幅度的削減。具體情況如下:我們第二季度的非公認會計準則營運費用包括約1500萬美元的預先承諾的直接面向消費者的廣告支出、700萬美元的在第三季度前無法終止的項目成本,以及前述的600萬美元的一次性重組費用。
We expect the reduction or elimination of spend in these areas to drive our continued cost-saving efforts. Accounting for these items, we expect Q3 non-GAAP operating expenses to be below $60 million and Q4 non-GAAP operating expenses to be below $55 million.
我們預計,這些領域支出的減少或取消將推動我們持續的成本節約工作。在計入這些項目後,我們預計第三季非公認會計準則營運支出將低於6,000萬美元,第四季非公認會計準則營運支出將低於5,500萬美元。
As a reminder, these projections reflect non-GAAP operating expenses, which excludes stock-based compensation and certain other non-cash items. We encourage our analysts and investors to account for this nuance in their modeling.
提醒一下,這些預測反映的是非公認會計準則下的營運費用,不包括股票薪資和某些其他非現金項目。我們鼓勵分析師和投資者在建模時考慮這一細微差別。
Based on our Q2 results and anticipated second half targets, we are lowering the upper range of our full year 2025 non-GAAP operating expense guidance by $15 million to $290 million to $305 million. For the quarter ended June 30, 2025, we reported gross profit of $34.5 million, which equates to a gross margin of 87%, consistent with last quarter.
根據我們第二季的業績和預期的下半年目標,我們將2025年全年非公認會計準則營運費用指引的上限下調1,500萬美元,至2.9億美元至3.05億美元。截至2025年6月30日的季度,我們報告的毛利為3,450萬美元,相當於87%的毛利率,與上一季持平。
After accounting for quarterly cash expenses, we reported a loss from operations, excluding stock-based compensation of $51.7 million. That is a 30% improvement compared to the previous quarter. Our non-GAAP adjusted net loss for Q2 2025 was $56.5 million or $0.79 per share compared to a loss of $73.3 million or $1.25 per share for the same period in 2024 and a loss of $77.1 million or $1.07 per share for the first quarter of 2025.
扣除季度現金支出後,我們報告的營運虧損(不包括股票薪酬)為5,170萬美元。與上一季相比,這一數字改善了30%。 2025年第二季度,我們非公認會計準則調整後的淨虧損為5650萬美元,即每股虧損0.79美元,而2024年同期的淨虧損為7330萬美元,即每股虧損1.25美元,2025年第一季的淨虧損為7710萬美元,即每股虧損11.07美元。
As with past quarters, reconciling items between GAAP and non-GAAP results included non-cash stock-based compensation, non-cash interest related to our revenue interest financing liability and non-cash interest expense related to the amortization of debt discount.
與過去幾季一樣,GAAP 和非 GAAP 結果之間的調節項目包括非現金股票薪酬、與我們的收入利息融資負債相關的非現金利息以及與債務折扣攤銷相關的非現金利息費用。
Lastly, as of June 30, 2025, our cash and cash equivalents totaled approximately $150 million. Based on our current revenue outlook and operating forecast, we expect our current cash balances can support operations through the point of achieving profitability in 2026, excluding stock-based compensation and without the need for additional equity financing.
最後,截至2025年6月30日,我們的現金及現金等價物總額約為1.5億美元。根據我們目前的收入預期和營運預測,我們預計目前的現金餘額足以支持公司營運直至2026年實現盈利(不包括股票薪酬,也無需額外的股權融資)。
We are encouraged by our results and remain confident in our ability to deliver strong revenue growth and maintain disciplined expense management through the second half of 2025.
我們對我們的業績感到鼓舞,並對我們在 2025 年下半年實現強勁收入成長和保持嚴格的費用管理的能力充滿信心。
With that, I'll now turn the call back over to Steve for his closing remarks. Steve?
說完這些,我現在將電話轉回給史蒂夫,請他作最後發言。史蒂夫?
Steven Basta - President, Chief Executive Officer, Director
Steven Basta - President, Chief Executive Officer, Director
Thank you, Robert, and thank you again to everyone for joining us today.
謝謝你,羅伯特,再次感謝大家今天加入我們。
As you've heard throughout the call, we are executing with discipline and momentum. VOQUEZNA continues to demonstrate growth, and we believe our strategic pivot to focus on gastroenterologists will enable an acceleration of that growth. This targeted approach will deepen engagement with our highest value prescribers and create an opportunity for increased adoption.
正如大家在整個電話會議中所聽到的,我們正以紀律性和強勁的勢頭執行。 VOQUEZNA 持續呈現成長勢頭,我們相信,我們專注於胃腸病專家的策略重點將加速這一成長。這種有針對性的方法將加深我們與最有價值的處方醫生的互動,並創造提高採用率的機會。
At the same time, we are delivering on our commitment to financial discipline. We believe we have a clear path to profitability in 2026. We are building a business that is not only growing but growing responsibly. With exclusivity anticipated into 2033 and our EoE Phase 2 trial set to begin later this year, we believe we are laying the groundwork for long-term value creation.
同時,我們正在履行對財務紀律的承諾。我們相信,我們擁有清晰的2026年獲利路徑。我們正在打造一家不僅在成長,而且在負責任地成長的企業。預計獨家經營權將持續到2033年,EoE二期臨床試驗將於今年稍後啟動,我們相信,我們正在為長期價值創造奠定基礎。
To our patients, our team and our shareholders, thank you. Your trust fuels our mission. We remain focused on our goal of delivering meaningful value through disciplined execution and durable growth.
感謝我們的患者、團隊和股東。你們的信任是我們使命的動力。我們將繼續專注於我們的目標,透過嚴謹的執行和持續的成長創造有意義的價值。
I'll now turn it over to the operator to facilitate a Q&A session. Operator?
現在我將把時間交給接線員,以便進行問答環節。接線生?
Operator
Operator
(Operator Instruction) Kristen Kluska, Cantor Fitzgerald.
(操作員指令)Kristen Kluska、Cantor Fitzgerald。
Kristen Kluska - Research Analyst
Kristen Kluska - Research Analyst
Hi. Good morning. Congrats on a great quarter and for your victory in the citizen petition. Good to put this behind you now. So in terms of the ways that you're going to drive more depth and frequency of writing prescriptions, can you give us a little bit more color about how the sales force will target that?
嗨,早安。恭喜您本季業績出色,也恭喜您在公民請願活動中取得勝利。很高興能把這件事拋諸腦後。那麼,關於您將如何提高處方的深度和頻率,能否詳細介紹銷售團隊將如何實現這一目標?
And how much of real-world practice right now is some of these physicians trying it in a few of their patients first, hearing how well it is and then recommending it to more patients under care?
那麼,目前在現實世界中,有多少醫生會先在少數患者身上嘗試這種方法,了解其療效,然後將其推薦給更多的患者呢?
Steven Basta - President, Chief Executive Officer, Director
Steven Basta - President, Chief Executive Officer, Director
Kristen, thanks so much for joining us, and thanks for starting us off with what I think is actually the core topic for the transition that we're making, which is the focus on gastroenterology and the focus on depth and frequency of writing.
克里斯汀,非常感謝您加入我們,也感謝您首先談到我認為我們正在進行的轉變的核心主題,即關注胃腸病學以及關注寫作的深度和頻率。
It's actually really quite simple and straightforward how we are targeting the sales reps. We've realigned all of the sales territories as of early July. So Q3, all of our sales reps now have a new target list that is different from the target list on which they've been operating over the past several quarters.
我們針對銷售代表的目標客群定位其實非常簡單直接。自7月初以來,我們已經重新調整了所有銷售區域。因此,在第三季度,我們所有的銷售代表現在都有一份新的目標客戶清單,這與他們過去幾季一直在使用的目標客戶清單有所不同。
That drops out north of 20,000 primary care physicians that we were calling on that just hadn't converted and hadn't written. Now we've obviously got a significant number of primary care physicians who have converted, but we were spending a lot of time trying to drive first adoption from physicians that would then write slowly.
我們聯繫的超過2萬名初級保健醫生還沒有轉換,也沒有寫信。現在,顯然已經有相當一部分初級保健醫生轉換了,但我們花了很多時間試圖推動第一批醫生採用,而這些醫生寫信的速度很慢。
What we're seeing instead as we look at our metrics is that there is a very strong correlation between call frequency and frequency of prescribing within the gastroenterology community. We had previously only been calling on the top half of the gastroenterology community decile based upon prescribing. We've now added all gastroenterologists into the call pattern and into the target list for the sales reps.
相反,當我們查看指標時,我們發現胃腸病學界的來電頻率和開藥頻率之間有非常強烈的相關性。之前,我們只根據開藥情況,對胃腸病學界中排名前半的醫生進行來電。現在,我們已將所有胃腸病學專家都加入了來電模式和銷售代表的目標客戶名單中。
And we are driving multiple sales calls per month into the key gastroenterology accounts. That allows our sales team to spend enough time in the offices to get to know every prescriber in that office to build comfort, build awareness, build experience with the product through sampling and through education of physicians that allows for an evolution of writing habits to much higher frequency writing.
我們每月都會對關鍵的胃腸病學客戶進行多次銷售拜訪。這使得我們的銷售團隊能夠在診所裡待足夠長的時間,了解診所裡的每一位處方醫生,從而透過抽樣和培訓來建立舒適感、提升認知度、累積產品使用經驗,最終幫助醫生養成更頻繁的書寫習慣。
Our internal metrics, when we look at what happens as we spend more time in physicians' offices clearly indicate that's a strategy that works, that the tactics of spending time, building those relationships, providing that education grows utilization.
當我們觀察在醫生辦公室花費更多時間時發生的情況時,我們的內部指標清楚地表明這是一個有效的策略,花費時間、建立關係、提供教育等策略可以提高利用率。
Even in our top gastroenterology accounts, we are still a moderate percentage of their overall GERD patient volume. There is still growth even among the top accounts. And then in the broader gastroenterology community where there's been some adoption, there isn't yet daily or weekly writing practice among all of those physicians, we're going to be able to achieve that by spending more time in those offices.
即使在我們頂級的胃腸病學客戶中,我們在其GERD患者總數中所佔的比例仍然不高。即使在頂級客戶中,我們的GERD患者數量仍在增加。在更廣泛的胃腸病學領域,雖然已經有一些醫生採用了我們的技術,但這些醫生還沒有養成每天或每週寫病歷的習慣,我們將透過在這些診所投入更多時間來實現這一目標。
So it's time and relationships that drives depth and frequency. And the real-world impact on that is as physicians get more comfortable with the product, they prescribe it more often. As they prescribe it more often, it's a self-reinforcing positive psychology that emerges because they hear from their patients how much better they feel, and that creates an acceleration.
所以,時間和人際關係決定了治療的深度和頻率。而這在現實世界中的影響是,隨著醫生對產品越來越熟悉,他們會更頻繁地開立這種藥。隨著他們開藥的頻率增加,一種自我強化的正向心理就會出現,因為他們會聽到病人說他們感覺好多了,這就會加速治療的進程。
We also think that there's going to be a bit of a broad community-based effect within gastroenterology that as we get more gastroenterologists to write, they talk to more of their colleagues who also have positive experiences, and that creates an uplift within that entire community.
我們也認為,這將在胃腸病學領域產生一種廣泛的社區效應,隨著越來越多的胃腸病學家撰寫文章,他們會與更多有積極經驗的同事交流,這會給整個社區帶來積極的影響。
Operator
Operator
Joseph Stringer, Needham & Company.
約瑟夫·斯特林格,Needham & Company。
Joseph Stringer - Analyst
Joseph Stringer - Analyst
Hi. Good morning. Thanks for taking our question. Congrats on the quarter. Just given your 2025 revenue guide of $165 million to $175 million and your comments on anticipated acceleration of revenue over the next few quarters, given your focus and traction with GI specialists, is that acceleration already baked into the current revenue guide? Or do you think this could be a driver to the upside?
您好,早安。感謝您回答我們的問題。恭喜本季取得佳績。鑑於您2025年的收入預期為1.65億至1.75億美元,並考慮到您對GI專家的關注和推動,您對未來幾季收入預期加速的評論,這種加速是否已經反映在當前的收入預期中?或者您認為這可能是推動公司業績上漲的因素?
Steven Basta - President, Chief Executive Officer, Director
Steven Basta - President, Chief Executive Officer, Director
I think absolutely, long term, it's a driver to the upside. What is hard to predict is how quickly it comes into our revenue numbers. And what I'm describing there is just as we add a significant number of new gastroenterology targets to the sales force, they start making sales calls, but we know that it can, in some cases, take 7, 10, 12 sales calls before a physician starts writing.
我認為,從長遠來看,這絕對是推動我們業務成長的動力。但很難預測的是,它對我們的收入數字貢獻速度有多快。我指的是,當我們的銷售團隊增加大量新的胃腸病學目標客戶時,他們就開始進行銷售拜訪,但我們知道,在某些情況下,醫生可能需要打7、10、12個電話才能開始寫信。
And then it takes another several calls for them to start changing habits and to grow their habits. Now that timeline is different for every physician. And for some of these physicians, they've already had a fair number of sales calls.
然後,他們又需要打幾通電話才能開始改變習慣,並養成習慣。每個醫生的時間表都不一樣。有些醫生已經打過不少銷售電話了。
So what I expect that we're going to see is that it may take one or two or three quarters before the new targeting strategy really starts to show a consistent acceleration in growth in revenue. But I think, again, our own metrics would suggest that that is going to happen, but it doesn't happen with the first sales call. It happens with multiple repeated visits to the office that happen gradually over a period of months.
因此,我預計新的目標策略可能需要一到兩個或三個季度才能真正開始展現收入持續加速成長的勢頭。不過,我認為,我們自己的指標也顯示這種情況會發生,但這並非第一次銷售拜訪就能實現。它需要幾個月內多次反覆拜訪辦公室,逐漸累積。
So in terms of our revenue guidance, I mean, the reason that we've provided guidance in a range that is above where analysts currently are, that's my expectation is that we're going to be in that $165 million to $175 million range.
因此,就我們的營收預測而言,我們之所以提供高於分析師目前預測的預測範圍,是因為我預計我們的營收將處於 1.65 億美元至 1.75 億美元的範圍內。
And I do believe that longer term, we're going to get acceleration, whether the acceleration comes within this time frame of the next two quarters or it's early in 2026, it's very hard for us to predict the date at which this new strategy really drives traction.
我確實相信,從長遠來看,我們將獲得加速,無論加速是在未來兩個季度內還是在 2026 年初發生,我們都很難預測這項新策略真正帶來推動作用的日期。
Operator
Operator
Annabel Sammy, Stifel.
安娜貝爾·薩米 (Annabel Sammy),Stifel。
Annabel Samimy - Analyst
Annabel Samimy - Analyst
Hi. Thanks for taking my question and thank you for the details on how you're targeting the GI docs. I guess my question is, and it makes total sense that you're focusing on the prescribers and at some point, that transitions into primary care writers. But I am curious, the acid control market became blockbuster category, I believe, through the primary care market.
您好。感謝您回答我的問題,也感謝您詳細說明您是如何瞄準胃腸科醫生的。我的問題是,您專注於處方醫生,並在某個階段轉向初級保健醫生,這完全合理。但我很好奇,我相信酸控制市場是透過初級保健市場發展成為重磅產品類別的。
So do you have any sense at what is the tipping point between the frequency of writing of the gastros and when that starts tipping into the primary care, what does that transition to get prescribing started in the primary care setting? So I guess that's the first question at what point that -- is there an inflection point that switches over to the primary care being the primary writers there.
那麼,您覺得胃腸病醫師的處方頻率和基層醫療之間的臨界點在哪裡呢?基層醫療機構如何開始開處方?我想,第一個問題是,在哪個臨界點上,是否存在一個轉捩點,讓基層醫療機構成為主要的處方撰寫者。
And maybe secondly, I did notice that you started this program to tap into the Medicare, Medicaid population. Is that going to over time impact your gross to nets more? How much is going to start having to go through Blink? I guess I'm trying to understand the longer-term dynamics of tapping into that market. Thanks.
其次,我注意到您啟動這個計畫是為了吸引聯邦醫療保險(Medicare)和醫療補助(Medicaid)的人。這會隨著時間的推移對您的總收入和淨收入產生更大的影響嗎?有多少資金需要通過Blink?我想了解進入這個市場的長期動態。謝謝。
Steven Basta - President, Chief Executive Officer, Director
Steven Basta - President, Chief Executive Officer, Director
So in thinking about the evolution from GI to primary care, in your question, there's almost a presumption that we have to be in primary care for this to be a blockbuster product. I don't actually think that's true. I think that there is well north of $1 billion revenue potential in GI alone.
所以,在思考從胃腸道到初級保健的演變時,正如你剛才提到的問題,幾乎有人假設,只有進入初級保健領域,它才能成為暢銷產品。但我並不這麼認為。我認為光是胃腸道領域就擁有遠超10億美元的收入潛力。
And that's also built on the precedent of the PPI experience that there are multiple PPIs that reached north of $1 billion of revenue in GI before they made a broadening push into primary care. So there is past history in the reflux market that adoption first in GI has been a well-worn strategy that multiple products have used, and that's driven the broader adoption. And the GI market is a meaningful market in and of itself.
這也建立在PPI(質子幫浦抑制劑)的經驗之上:在進軍初級保健領域之前,已有多種PPI在胃腸道領域取得了超過10億美元的收入。因此,在反流病市場中,先在胃腸道領域應用是一種行之有效的策略,許多產品都曾採用過,而這推動了更廣泛的應用。胃腸道市場本身就是一個意義重大的市場。
It's also where there is the greatest concentration of need for our product. So if you think about the broad population of patients in a primary care office, the portion of patients who are experiencing the most discomfort from their heartburn, who are experiencing the most pain, get referred to GI.
這也是我們產品需求最集中的地方。所以,如果你想想初級保健診所的廣大患者群體,你會發現,那些胃灼熱不適感最強烈、疼痛最劇烈的患者會被轉診到胃腸道科。
So the distribution of patients in GI needing a more potent reflux treatment is higher and is going to drive faster acceleration. So my expectation is this becomes a blockbuster product in GI alone. And then the PCP market is meaningfully additive. We have significant revenue potential and significant runway in GI.
因此,在胃腸道疾病中需要更強效逆流治療的患者比例更高,這將推動該藥物的快速發展。我預計,該藥物將成為胃腸道疾病領域的重磅產品。此外,PCP(處方藥)市場也將顯著成長。我們在胃腸道疾病領域擁有巨大的收入潛力和廣闊的發展空間。
So I don't perceive GI as a starting point and then it transitions to a primary focus on PCP. I view GI as a constant growth driver and then PCP to be meaningfully additive and expanding the market to add significant revenue on top of the GI opportunity.
因此,我不認為GI只是個起點,之後會轉向PCP作為主要關注點。我認為GI是持續的成長動力,而PCP則具有顯著的附加價值,能夠擴大市場,在GI機會的基礎上帶來顯著的收入成長。
The second question regarding Medicare, we're really viewing Medicare as not the future revenue driver population because we still get a low percentage of Medicare patients that achieve coverage. The majority of Medicare scripts that go through end up being cash pay scripts that run through the Blink program.
第二個問題是關於Medicare的,我們實際上認為Medicare並非未來收入的主要驅動力,因為目前獲得醫保覆蓋的Medicare患者比例仍然很低。大多數Medicare處方最終都是透過Blink計畫支付的現金處方。
The intent of creating the cash pay alternative for those Medicare patients that don't have coverage is really around both supporting patients that there are patients who need our drug and this provides them access to it and supporting physicians to make it easier for a physician to prescribe the product and to be agnostic as to whether their patient is on commercial insurance or Medicare.
為沒有醫療保險覆蓋的病人提供現金支付替代方案的目的實際上是為了支持病人,讓病人知道有病人需要我們的藥物,並讓他們能夠獲得藥物,同時支持醫生,讓醫生更容易開出產品,並且無需擔心他們的病人是否參加商業保險或醫療保險。
We don't want the physician to have to think twice about, is my patient going to get this product covered? Do I want to prescribe it? We want them to just adopt the habit of prescribing. And for every patient that they perceive needs it, go ahead and prescribe it, go ahead and send it through to Blink.
我們不想讓醫生再三考慮:我的病人能不能享受這個產品的保障?我是否要開這個處方?我們希望他們養成開處方的習慣。對於他們認為需要的每一個病人,直接開處方,直接發送給Blink。
If it's a commercial patient and they get covered, then that's a covered script. And if it's a Medicare patient and they need the cash pay option, Blink can provide the cash pay option. So it just makes it easier for an HCP to adopt the product and to do so broadly in their practice.
如果是商業患者,而且他們有醫保,那麼處方就屬於承保範圍。如果是健保患者,並且需要現金支付選項,Blink 可以提供現金支付選項。因此,這讓醫護人員更容易採用該產品,並在實務上廣泛推廣。
Operator
Operator
Yatin Suneja, Guggenheim.
古根漢美術館的亞廷·蘇內賈(Yatin Suneja)。
Yatin Suneja - Equity Analyst
Yatin Suneja - Equity Analyst
Hey guys, thank you for taking my questions. Congratulations, very nice quarter. And I must add impressive above consensus guide because it's really helpful for us in light of all the cost cutting that you're doing. So the question from me is twofold. Number one, where exactly are you cutting costs? And how might that impact growth trajectory, if any?
大家好,感謝你們回答我的問題。恭喜,這個季度表現非常出色。另外,我必須補充一點,高於市場預期的表現令人印象深刻,因為考慮到你們正在實施的成本削減措施,這對我們來說非常有幫助。所以我的問題有兩面。第一,你們究竟在哪些方面削減了成本?如果真的會削減成本,這會對成長軌跡產生什麼影響?
And then when you talk about the $55 million cash OpEx in 4Q, should that be considered a steady state as we go into 2026? Or maybe just help us understand how should we think about that because if that's the number, we think you could become profitable when the sales reach somewhere in the $70 million to $75 million range. So I just wanted to check if we are in the right ballpark there. Thank you so much.
然後,您說第四季的現金營運支出為5500萬美元,這是否應該被視為2026年的穩定狀態?或者您能不能幫我們理解一下應該如何理解這個數字,因為如果是這個數字,我們認為當銷售額達到7000萬到7500萬美元左右時,你們就有可能盈利。所以我只是想確認一下我們這個估算是否準確。非常感謝。
Steven Basta - President, Chief Executive Officer, Director
Steven Basta - President, Chief Executive Officer, Director
Perfect. Thanks for the questions. I think those are going to be helpful in clarifying to a number of folks as they're thinking about modeling this for the future.
太好了。謝謝你的提問。我認為這些問題將有助於澄清一些正在思考未來建模的人。
So first, where we're cutting costs to get to the $60 million in Q3 and the $55 million in Q4 comes from several categories. The first and the biggest cost savings is actually eliminating our direct-to-consumer promotional program. That becomes a big line-item savings.
首先,我們削減了成本,使第三季的支出達到6,000萬美元,第四季的支出達到5,500萬美元,這些成本來自幾個方面。第一個也是最大的成本節省實際上是取消了直接面向消費者的促銷計劃。這帶來了很大的單項成本節省。
And for context there on how we're doing that and not impacting revenue is my own assessment of that program and our internal metrics would suggest that program was just run prematurely that we ran that program at a time when there is not yet broad adoption in the primary care community.
關於我們如何做到這一點並且不影響收入的背景是我自己對該計劃的評估,我們的內部指標表明該計劃運行過早,我們在初級保健社區尚未廣泛採用時運行了該計劃。
And if a DTC program is to work, it is intended to activate patients to drive them to primary care, but we don't have enough primary care physicians who are yet writing scripts. And so, we were driving patients to physicians who don't know the drug and weren't writing and we just weren't getting a return on it.
如果DTC計畫要發揮作用,其目的是激勵患者前往初級保健機構,但我們目前缺乏足夠的初級保健醫生來開藥。因此,我們只能把病人送到那些不了解藥物、不開藥的醫生那裡,最終得不到任何回報。
So by reducing that spend, we're not expecting an adverse impact on revenue. We actually think that instead, we're going to see more uplift in revenue because of the retargeting strategy on GIs, which improves sales force productivity. So that's the first most significant area.
因此,透過減少這部分支出,我們預計不會對收入產生負面影響。實際上,我們認為,由於地理標示的再行銷策略提高了銷售團隊的生產力,我們的收入反而會進一步成長。所以這是最重要的領域。
We did do a small restructuring, a modest percentage of total headcount restructuring that will provide some savings as well. There are a significant number of savings that come from third-party vendor contracts that we are adjusting. And just across the board, we're creating fiscal discipline in how we are driving third-party spend.
我們確實進行了小規模重組,佔總員工重組的一小部分,也將帶來一些成本節省。我們正在調整第三方供應商合同,從而節省了大量成本。此外,我們正在全面規範第三方支出的財務紀律。
So whether it's a marketing-related vendor that is developing marketing materials where we can do things more cost effectively using AI or using internal resources rather than using outside vendor, there's significant savings in that process. So just across the board in a number of areas, we've identified primarily third-party vendor costs that could be reduced and not adversely impact revenue. So we are seeing that already take effect.
因此,無論是與行銷相關的供應商開發行銷材料(我們可以使用人工智慧更經濟高效地完成工作),還是使用內部資源而非外部供應商,都能顯著節省成本。因此,在多個領域,我們已經確定了主要可以降低且不會對收入產生不利影響的第三方供應商成本。我們已經看到這些措施正在產生效果。
As Robert described, we effectively reduced costs by $18 million from Q1 to Q2 in terms of OpEx. Now that was offset by restructuring charges of $6 million that we took in, but you see already from Q1 to Q2, a significant operating reduction recognized. Those operating savings were implemented mid-quarter.
正如羅伯特所述,從第一季到第二季度,我們有效地降低了1800萬美元的營運成本。這筆成本被我們收取的600萬美元重組費用所抵銷。但您已經看到,從第一季到第二季度,我們實現了顯著的營運成本削減。這些營運成本的削減是在季度中期實施的。
So we're already at that substantially toward that reduced run rate because we realized those cost savings for the second half of the quarter. We've got clear line of sight visibility to get to the $60 million in Q3 and to get to the $55 million target in Q4 with rigorous investment still in our core sales tactics strategy.
因此,由於我們在本季下半段實現了成本節約,我們已經大幅接近降低的運行率目標。我們清楚知道,第三季將達到6,000萬美元的目標,第四季將達到5,500萬美元的目標,同時我們仍將對核心銷售策略進行嚴格的投資。
The second element of your question on how to think about the $55 million in Q4 and the go forward, we haven't yet forecasted or published a 2026 OpEx run rate. You should expect that our 2026 OpEx run rate will reflect the significant cost savings that we've had, but there may be some incremental investments that we choose to make in 2026.
您問題的第二個面向是關於如何看待第四季的5500萬美元以及未來的發展,我們尚未預測或公佈2026年的營運支出運行率。您應該預期,我們2026年的營運支出運行率將反映我們已經實現的大幅成本節約,但我們可能會選擇在2026年進行一些增量投資。
So we're not committing that we're going to hold exactly to the $55 million number. There could be some things that we choose to do that either are revenue-enhancing activities or the clinical trial activities. Obviously, we're starting our EoE study in Q4. That's built into the $55 million number. But that obviously will also have expenses into next year.
因此,我們不會承諾嚴格控制在 5500 萬美元這個數字上。我們可能會選擇進行一些增收活動或臨床試驗。顯然,我們將在第四季啟動 EoE 研究。這已經包含在 5500 萬美元的數字中了。但這顯然也會影響明年的支出。
So there may be some things that we add. The 2026 number might be a slightly higher run rate than that $55 million. We haven't communicated exactly what that magnitude is because we haven't built out our operating plan in that level of detail yet for 2026. But it will be substantially below where the company had been over past quarters.
所以我們可能會增加一些內容。 2026年的營運成本可能會比5,500萬美元略高。我們還沒有確切地說明這個數字,因為我們還沒有製定2026年的詳細營運計畫。但這將大大低於公司過去幾季的水平。
Operator
Operator
Paul Choi, Goldman Sachs.
高盛的保羅·崔(Paul Choi)。
Paul Choi - Analyst
Paul Choi - Analyst
Hi. Thank you. Congratulations on all the progress. It's good to see you guys going back into the clinic as well for EoE. Can you maybe comment just a little bit on what physician feedback is in that space between generic PPIs and other conventional therapies and the transition into biologics and just what physicians would look for an intermediate therapy potentially such as vonoprazan there?
你好,謝謝。祝賀你們取得的所有進展。很高興看到你們重返臨床,繼續治療EoE。您能否簡單談談醫生們對仿製PPI、其他傳統療法以及向生物製劑過渡的反饋,以及醫生們會尋找哪些中間療法,例如沃諾拉贊?
And my second question is, can you maybe just comment on how you're thinking about the timing for the pediatric study? It's been something that's been in there in the background. I'm just wondering if that's something you would consider starting in 2026. Thanks for taking our questions.
我的第二個問題是,您能否談談您對兒科研究時間安排的看法?這方面一直在醞釀。我想知道您是否考慮在2026年開始進行。感謝您回答我們的問題。
Steven Basta - President, Chief Executive Officer, Director
Steven Basta - President, Chief Executive Officer, Director
I'm sorry, which study was that that you were asking about, Paul, the second one?
抱歉,保羅,您問的是哪一項研究,第二項嗎?
Paul Choi - Analyst
Paul Choi - Analyst
A pediatric to get the additional exclusivity period.
兒科獲得額外的獨佔期。
Steven Basta - President, Chief Executive Officer, Director
Steven Basta - President, Chief Executive Officer, Director
Got it. Okay. So in thinking about the EoE opportunity, I think you've hit upon both elements of thinking strategically about the EoE opportunity. There's one element of it, which is the EoE market in and of itself represents an incremental revenue opportunity for us. There's a second element of it, which is that the EoE strategy potentially provides us a path to a written request and the pediatric exclusivity strategy.
明白了。好的。所以,在思考 EoE 機會時,我認為您已經觸及了策略性思考 EoE 機會的兩個要素。其中一個要素是,EoE 市場本身就代表著我們一個增量收入機會。第二個要素是,EoE 策略可能為我們提供了一條獲得書面申請和兒科專營權策略的途徑。
So the first part of it in terms of the market opportunity, today, PPI therapy is first-line therapy in EoE patients. Even though there isn't a large clinical trial that has demonstrated efficacy, there are enough case reports or are enough published experience studies.
就市場機會而言,首先,PPI 療法目前是 EoE 患者的第一線治療方案。儘管目前尚無大型臨床試驗證明其療效,但已有足夠多的病例報告或已發表的經驗研究。
There is enough experience on the part of physicians and mechanistic data that shows that modifying acid in the stomach has a beneficial impact on EoE, both the histology and the symptoms in that condition that standard PPI therapy has become standard of care first-line treatment.
醫生擁有足夠的經驗和機制數據,表明改變胃酸對 EoE 有益的影響,包括該病症的組織學和症狀,因此標準 PPI 療法已成為標準的一線治療。
There is a meaningful opportunity to disrupt that and have vonoprazan potentially become the first-line treatment rather than PPIs with meaningful clinical data that represents a significant large data set that shows efficacy shows the magnitude of improvement. There are case reports from Japan that show significant improvement in histology with vonoprazan.
打破這一現狀,讓沃諾拉贊有可能取代PPI成為一線治療藥物,這是一個意義重大的機會。沃諾拉贊擁有豐富的臨床數據,這些數據代表著一個龐大的數據集,能夠證明療效和改善程度。日本的病例報告顯示,沃諾拉讚的組織學顯著改善。
That underlying data set supports the thesis that we are going to be able to have a fundamental positive impact on these patients through vonoprazan therapy. And there's a possibility that this is, as you described, an intermediate step that first-line therapy is PPIs and then patients graduate to vonoprazan.
這些基礎數據支持了我們的論點:我們將能夠透過沃諾拉贊療法對這些患者產生根本性的正面影響。而且,正如您所描述的,這有可能是一個中間步驟:第一線治療採用PPI,然後患者逐漸過渡到沃諾拉贊。
There's also a possibility that this becomes the first-line therapy and changes the nature of the treatment paradigm over time as we get clinical data that it actually gets adopted more broadly. But that's to be determined down the road as we get the clinical data from those studies. But that represents a meaningful upside revenue opportunity.
隨著我們獲得臨床數據,並最終被更廣泛地採用,它也有可能成為一線療法,並隨著時間的推移改變治療模式的性質。但這還有待我們日後從這些研究中取得臨床數據後才能確定。但這代表著一個有意義的增值收入機會。
The second half of the value proposition of EoE is as you described the pediatric exclusivity extension. This first trial is going to be in adults-only. So this is not going to provide the pediatric exclusivity extension, but it is intended to lead to an end of Phase 2 meeting and a conversation with FDA about a written request in our past conversations with FDA, they've indicated this could be a potential pediatric indication that would warrant that discussion.
EoE 價值主張的後半部分,正如您所描述的,是兒科獨佔權的延長。首次試驗將僅針對成人。因此,這不會延長兒科獨佔權,但其目的是促成第二階段會議的結束,並與 FDA 就書面申請進行溝通。在我們過去與 FDA 的溝通中,他們表示這可能是潛在的兒科適應症,值得討論。
And so, we're making no commitments about it because we don't have a commitment from the FDA in this regard, but we have had conversations where there's a possibility of getting a request associated with the Phase 3 program for EoE that would provide that six-month exclusivity extension. So that path will be determined at the end of this Phase 2 trial.
因此,我們不會對此做出任何承諾,因為我們尚未獲得FDA在這方面的承諾,但我們已進行過溝通,有可能獲得與EoE 3期計畫相關的申請,從而延長6個月的獨佔期。因此,具體方案將在第二階段試驗結束時確定。
Operator
Operator
Umer Raffat, Evercore ISI.
Umer Raffat,Evercore ISI。
Unidentified Participant
Unidentified Participant
This is [Jason] on for Umer. Two questions, if I may. The first question is on ex-US strategy. I think the drug pricing letter was sent to a selected 17 companies, not the broad industry.
我是[Jason],代表Umer發言。請容許我問兩個問題。第一個問題是關於美國以外的戰略。我認為藥品定價函是發給選定的17家公司的,而不是整個產業。
And the scope looks like it's going to be limited within just Medicaid. So we don't know if this will change later, but at least for now, the impact on your business is likely very small. So how are you thinking about your strategy in the ex-US market?
而且範圍似乎僅限於醫療補助(Medicaid)。所以我們不知道以後這種情況是否會改變,但至少目前,對您的業務影響可能很小。那麼您如何考慮在美國以外市場的策略?
And secondly, when I was looking at some of the historic data presented at the medical conferences, there were about 22% patients cycle through two lines of PPI and another 14 to 17 cycle through more than three lines of PPI.
其次,當我查看醫學會議上提供的一些歷史資料時,發現大約有 22% 的患者使用兩種 PPI 藥物,另有 14% 到 17% 的患者使用三種以上的 PPI 藥物。
I guess my question is, is this a result of the requirement on the step edits? Or is this just a pattern of how the doctors are prescribing VOQREZNA? And is it going to change where more and more patients switch to VOQUEZNA after just one line of?
我的問題是,這是因為對步驟編輯的要求嗎?還是這只是醫生開VOQREZNA的處方模式?這種情況會改變嗎?越來越多的病人在只服用了一行VOQUEZNA後就改用VOQUEZNA?
Steven Basta - President, Chief Executive Officer, Director
Steven Basta - President, Chief Executive Officer, Director
So let's take each part of that separately. So the first part on the ex-US strategy, at the current time, we're just focused on the US market. We are not spending a significant amount of time thinking through what our launch strategy would be in Europe or in Canada.
那麼,讓我們分別來討論一下這幾個部分。第一部分是關於美國以外地區的策略,目前我們只專注於美國市場。我們並沒有花太多時間去思考在歐洲或加拿大的發布策略。
We have rights to vonoprazan for three territories for the US, for Europe and Canada. All of our commercial activities are focused on the US, all of the focus of how do we drive our business focused on US.
我們擁有沃諾拉贊在美國、歐洲和加拿大三個地區的銷售權。我們所有的商業活動都集中在美國,我們所有的業務發展也都集中在美國。
The European and Canadian opportunities represent potential upside opportunities, but they also come with the complications of the current market that you described, which is all of the issues around most favorite nations, pricing, et cetera. And so, we're just not, at this point, anticipating any near-term activities in terms of our own launch in the European market.
歐洲和加拿大市場代表著潛在的上漲機會,但也伴隨著您所描述的當前市場的複雜性,例如圍繞我們最青睞的國家、定價等等諸多問題。因此,我們目前還不打算在近期內啟動我們在歐洲市場的計畫。
We have in the past had conversations with potential European partners around a potential launch. We might elect to do that at some point in time, but that's not the current strategy, but always a possibility that we might explore.
我們過去曾與潛在的歐洲合作夥伴就推出產品的可能性進行過洽談。我們可能會選擇在某個時間點這樣做,但這不是目前的策略,但我們總是會探索這個可能性。
The second half of your question around whether patients fail one PPI, two PPIs or three PPIs prior to getting vonoprazan, that evolves over time as physicians get more and more comfortable with this therapy. So what you're seeing in terms of patients who have been on two PPIs or three PPIs, it's actually just a reflection of the fact that 30% to 40% of patients on PPI therapy are still experiencing pain.
您問題的後半部是關於患者在服用沃諾拉贊之前,是服用一種、兩種還是三種PPI藥物後出現疼痛,這個問題會隨著醫生對這種療法越來越熟悉而逐漸發生變化。所以,您所觀察到的服用過兩種或三種PPI藥物的患者的情況,實際上只是反映了一個事實:在接受PPI治療的患者中,仍有30%到40%的人感到疼痛。
So it's interesting when we do market research and we look at what physician's report about who the patients are that are appropriate for vonoprazan, some of them indicate a patient who's failed one round of PPI therapy. Some indicate patients who failed two rounds of PPI therapy.
所以,當我們進行市場研究並查看醫生關於哪些患者適合使用沃諾拉讚的報告時,發現很有趣的是,有些醫生的報告指出患者已經接受過一輪PPI治療但失敗了。有些醫生的報告指出患者已經接受過兩輪PPI治療但失敗了。
Some indicate a patient who's on PPI therapy and also adjunct acids. Some indicate a patient who's on PPI therapy and now is double dosing. All of those are manifestations of exactly the same phenomenon, which is a patient who's been on PPI therapy and is still experiencing heartburn. That's our core patient.
有些病例顯示患者正在接受PPI治療,同時也服用輔助酸劑。有些病例顯示患者正在接受PPI治療,現在劑量加倍。所有這些都是同一種現象的表現,即患者一直在接受PPI治療,但仍然感到胃灼熱。這類患者就是我們的核心患者。
All of those strategies are different things that physicians have tried or have recommended to patients that they try to manage their ongoing heartburn, but the phenomenon is exactly the same, which is you've got a patient who's on a PPI who's not adequately resolving their heartburn and they need something more, they need something better. That's the patient we're going to try to switch.
所有這些策略都是醫生嘗試過或推薦給患者的,旨在控制持續的胃灼熱,但其效果完全相同:患者正在服用PPI,但胃灼熱症狀沒有得到充分緩解,他們需要更多、更好的治療。這就是我們要嘗試治療的患者。
And it will just vary by physician practice as to whether they have been through two or three PPI therapies over the time. Over time, where I think that goes is it gravitates toward when you fail one PPI, why am I switching you from omeprazole to esomeprazole.
醫生是否接受過兩到三種PPI治療,也會因醫師的實踐而異。隨著時間的推移,我認為最終結果是,當你接受過一種PPI治療失敗後,我為什麼要把你的奧美拉唑換成埃索美拉唑呢?
That's not going to really do anything. If you're failing on omeprazole, you should be switching to our drug. That evolution and thinking is going to come over the course of the coming years of physician experience with this drug.
這根本沒什麼用。如果奧美拉唑對你無效,你應該換用我們的藥。這種轉變和想法將在未來幾年醫師使用該藥的過程中逐漸顯現。
Operator
Operator
Matthew Caufield, H.C. Wainwright.
馬修·考菲爾德、H.C. 溫賴特。
Matthew Caufield - Analyst
Matthew Caufield - Analyst
Hi. Good morning, guys, and congrats on the progress. So it was helpful to see the 68% retail pharmacy filled prescriptions with the remainder coming through the BlinkRx cash pay. So I was wondering, at this point, what is your sense of the steady-state balance between those two? And can you also comment on the current average BlinkRx cash pay amount? Thanks again.
大家好。早安,祝賀你們的進展。看到68%的處方藥來自零售藥局,其餘的則透過BlinkRx現金支付,這很有幫助。所以,我想知道,目前您認為這兩者之間的穩定平衡如何?能否談談目前BlinkRx現金支付的平均金額?再次感謝。
Steven Basta - President, Chief Executive Officer, Director
Steven Basta - President, Chief Executive Officer, Director
So it's hard for us to predict what the future steady-state average will be. Obviously, we are seeing both channels growing and by the way, some of the retail filled scripts actually have gone through Blink and then went to retail pharmacy. So we're seeing both the covered retail scripts growing and the Blink cash pay scripts growing.
因此,我們很難預測未來的穩態平均值。顯然,我們看到兩個管道都在增長,順便說一句,一些零售處方實際上是透過Blink分銷,然後進入零售藥局的。因此,我們看到覆蓋的零售處方和Blink現金支付處方都在成長。
We don't try to manage the business to manage what that ratio is. We try to grow all scripts, and both channels will continue growing. And so, our conversations with physicians are around driving prescription growth. And the guidance to a physician is if you just send it to Blink, it will be easy.
我們不會試圖透過管理業務來控制這個比例。我們致力於促進所有處方的成長,並且兩個管道都將繼續成長。因此,我們與醫生的溝通重點是推動處方成長。我們給醫生的建議是,只要把資料傳送給Blink,一切都很容易。
If it's a commercial script and it gets covered, they'll help you with the PA, they'll run the process to try to make sure that this can run through smoothly. And so, it streamlines the process for getting a patient the script if it gets covered, and it also streamlines the process for getting the patient the option to pay cash if it's not covered. And so that's a win-win for the physician and for the patient.
如果是商業處方,並且得到了醫療保險承保,他們會協助您辦理個人助理 (PA),並負責整個流程,確保一切順利進行。這樣一來,如果處方得到了醫保承保,患者獲得處方的流程就簡化了;如果處方沒有得到醫保承保,患者選擇現金支付的流程也簡化了。這對醫生和患者來說都是雙贏的。
So we're just trying to drive overall script volume, and we don't try to manage to a ratio. We just try to grow both. And we don't consciously say we're growing cash pay or we're growing prescription or growing covered, we are growing scripts and then allowing the best outcome for the patient and for insurance coverage in that process. So there's not an active attempt to try to adjust those.
因此,我們只是努力提高整體處方量,而不是試圖控制某個比例。我們只是努力同時成長兩者。我們不會刻意地宣稱要增加現金支付、增加處方量或增加健保覆蓋率,而是增加處方量,並在這過程中為病患和健保覆蓋率爭取最佳結果。因此,我們並沒有主動嘗試調整這些因素。
Was there a second half to your question that I missed in that process?
在此過程中我是否錯過了您問題的後半部分?
Matthew Caufield - Analyst
Matthew Caufield - Analyst
No. That was very helpful. Yeah. The second part was just if there's a sense of the average BlinkRx cash pay amount that patients could be paying in that category.
不,這很有幫助。是的。第二部分是,您是否了解患者在該類別中可以支付的平均 BlinkRx 現金支付金額。
Steven Basta - President, Chief Executive Officer, Director
Steven Basta - President, Chief Executive Officer, Director
So Blink, the standard cash pay amount that they pay is $50. So a patient will be offered a $25 co-pay if they get insurance coverage so that they have a lower co-pay if they're covered. But if their insurance plan is not covering the product, then they're offered the $50 cash pay option.
Blink 的標準現金支付金額是 50 美元。也就是說,如果患者有保險,他們只需支付 25 美元的共付額,這樣他們就可以在有保險的情況下降低共付額。但如果他們的保險計劃不涵蓋該產品,他們可以選擇 50 美元的現金支付。
Matthew Caufield - Analyst
Matthew Caufield - Analyst
Got it, very helpful. Thank you, guys, and great to see the progress again.
明白了,非常有幫助。謝謝大家,很高興再次看到進展。
Operator
Operator
And I'm not showing any further questions in the queue. And as such, this does conclude today's presentation. We thank you for your participation. You may all disconnect and have a wonderful day.
我不會在隊列中顯示任何其他問題。今天的演示到此結束。感謝大家的參與。大家可以斷開連接,祝福大家有美好的一天。