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Operator
Operator
Welcome to the Ardelyx first quarter 2026 earnings call. (Operator Instructions). I would now like to turn the conference over to Lisa Caperelli, Senior Vice President of Corporate Communications and Investor Relations. Lisa, you may begin.
歡迎參加 Ardelyx 2026 年第一季財報電話會議。(接線員指示)現在我想把會議交給 Ardelyx 企業傳播與投資人關係資深副總裁 Lisa Caperelli。Lisa,請開始。
Lisa Caperelli - SVP, Investor Relations and Corporate Communication
Lisa Caperelli - SVP, Investor Relations and Corporate Communication
Thank you, Ross. Good afternoon, everyone, and welcome to our first quarter 2026 financial results and business update call. Earlier today, we issued our earnings release, which can be found on the Investor section of our website at ardelix.com.
謝謝你,Ross。各位下午好,歡迎參加我們 2026 年第一季財務結果與業務更新電話會議。今天稍早,我們已發布財報新聞稿,可於 ardelix.com 網站的投資人專區查閱。
Slides that accompany today's call can also be found on our website. On today's call, I'm joined by Mike Raab, President and CEO of Ardelyx; who will share our Q1 progress towards our 2026 priorities. Eric Foster, Chief Commercial Officer, will provide an update on the performance of IBSRELA and XPHOZAH. And Sue Hohenleitner, our Chief Financial Officer, will provide some key highlights from our financial results.
今日電話會議所搭配的簡報也可在我們網站上找到。今天與我一同出席的有 Ardelyx 總裁暨執行長 Mike Raab,他將分享我們第一季在推進 2026 年優先事項方面的進展。商務長 Eric Foster 將就 IBSRELA 與 XPHOZAH 的表現提供最新資訊。我們的財務長 Sue Hohenleitner 將提供財務結果的幾項重點摘要。
Before we begin, I'd like to remind you that some of the statements made during the call today are forward-looking statements, which are subject to a number of risks and uncertainties that may cause our actual results to differ materially, including those described in our annual report on Form 10-K, our quarterly report on Form 10-Q, which was filed today, and from time to time in our other documents filed with the SEC.
在開始之前,我想提醒各位,今天電話會議中的部分陳述屬於前瞻性陳述,可能受到多項風險與不確定性影響,導致我們的實際結果與陳述內容出現重大差異;相關風險已載於我們的 Form 10-K 年度報告、今日提交的 Form 10-Q 季度報告,以及我們不時向美國證券交易委員會(SEC)提交的其他文件中。
While we may elect to update these forward-looking statements in the future, we specifically disclaim any obligations to do so, even if our views change.
雖然我們未來可能選擇更新這些前瞻性陳述,但即使我們的觀點有所改變,我們亦明確聲明不負有任何更新義務。
I will now pass the call over to Mike. Mike?
現在我把電話交給 Mike。Mike?
Michael Raab - President, Chief Executive Officer, Director
Michael Raab - President, Chief Executive Officer, Director
Thank you, Lisa. Good afternoon, everyone. It's great to be with all of you today. Before we dive in, I want to take a moment to welcome Lisa to the team. We're excited to have her on board, leading our IR efforts as our new Head of Investor Relations.
謝謝你,Lisa。各位下午好。很高興今天能與各位相聚。在開始之前,我想花點時間歡迎 Lisa 加入團隊。我們很高興她加入並擔任新的投資人關係主管,領導我們的投資人關係(IR)工作。
2026 is poised to be another significant year of growth for our company, and we're already off to a great start. At Ardelyx, we're building an innovative pipeline of medicines for patients with unmet medical needs. Our first quarter's performance reinforces our confidence in the strategy we've laid out and in our ability to capture the opportunities ahead to create long-term value.
2026 年可望成為公司另一個重要的成長年度,而我們已經有了很好的開局。在 Ardelyx,我們正打造一條創新的藥物研發管線,服務尚未被滿足醫療需求的患者。我們第一季的表現強化了我們對既定策略以及把握未來機會、創造長期價值能力的信心。
As we build on this momentum, our focus is on executing on our four key priorities: accelerating the growth of IBSRELA. Maintaining the exposure momentum, building and expanding our pipeline and delivering strong financial results. Starting with IBSRELA, in the first quarter, our disciplined commercial execution drove 58% year-over-year revenue growth.
在延續這股動能之際,我們的重點是落實四項關鍵優先事項:加速 IBSRELA 的成長、維持 XPHOZAH 的動能、建立並擴展研發管線,以及交出強勁的財務成果。先從 IBSRELA 談起,第一季我們以嚴謹的商業執行帶動產品營收年增 58%。
With more than 7 million prescriptions written for IBS-C-indicated medicines last year, IBSRELA is well positioned as a differentiated mechanism for patients who continue to experience symptoms despite treatment with a secretagogue.
去年針對 IBS-C 適應症的藥物處方量超過 700 萬張,IBSRELA 以其差異化作用機轉,對於即使接受促分泌劑(secretagogue)治療仍持續有症狀的患者,具備良好定位。
Our strategy continues to positively impact demand drivers, and today, IBSRELA is helping tens of thousands of patients with IBS-C, and we remain on track to deliver at least $1 billion in annual revenue in 2029.
我們的策略持續對需求驅動因素產生正面影響;目前 IBSRELA 正在幫助數以萬計的 IBS-C 患者,我們仍按計畫在 2029 年達成至少 10 億美元的年度營收。
With XPHOZAH, our patient first strategy continues to guide our execution with demand growing. Today, more patients have access to XPHOZAH than ever before, and we remain committed to supporting patients irrespective of payer coverage.
在 XPHOZAH 方面,我們以患者優先的策略持續指引執行,需求也在成長。如今,獲得 XPHOZAH 的患者比以往任何時候都更多;我們仍致力於不論付款方(payer)給付狀況如何,都支持患者。
Next, our pipeline. As a result of our performance and execution, we are at a stage where we have the financial flexibility to further invest in our pipeline, positioning our company for durable long-term growth. Earlier this year, we initiated ACCEL trial, a Phase 3 clinical trial evaluating the IBSRELA for chronic idiopathic constipation, or CIC, as part of our efforts to expand our label and to reach more patients.
接著談研發管線。憑藉我們的表現與執行力,我們已具備進一步投資研發管線的財務彈性,讓公司能維持長期且穩健的成長。年初我們啟動 ACCEL 試驗,這是一項第 3 期臨床試驗,評估 IBSRELA 用於慢性特發性便祕(chronic idiopathic constipation,CIC),作為我們擴大適應症標籤並觸及更多患者努力的一部分。
This trial has rapidly gained attention from clinicians and patients alike, and all pre-identified sites have been initiated in under four months and are engaged in patient recruitment activities. We remain on track to complete enrollment by year-end and to announce top-line data in the second-half of 2027. If ACCEL reads positive, it's relevant to expand treatment options for more patients.
此試驗迅速獲得臨床醫師與患者的關注;所有預先選定的試驗中心在不到四個月內即完成啟動,並已投入患者招募活動。我們仍按計畫在年底前完成收案,並於 2027 年下半年公布主要(top-line)數據。若 ACCEL 結果為正,將有助於為更多患者擴增治療選項。
In addition, we have a strategy to expand the use of IBSRELA, which may help pediatric patients with IBS-C and has the potential to extend [tenapanor] patent life for an additional six months.
此外,我們也有一項擴大 IBSRELA 使用的策略,可能可幫助 IBS-C 的兒科患者,並有機會將 [tenapanor] 的專利期限延長額外六個月。
Our ongoing pediatric program consists of several studies evaluating IBSRELA in patients with IBS-C and functional constipation, pediatric equivalent to adult CIC.
我們持續進行的兒科計畫包含多項研究,評估 IBSRELA 用於 IBS-C 與功能性便祕患者;功能性便祕可視為成人 CIC 的兒科對應疾病。
This effort is an example of our ongoing strategy to extend tenapanor, which includes our recently announced Orange Book listed 2,099 patent covering the commercial formulations of IBSRELA and XPHOZAH, building additional value for these franchises.
這項工作是我們持續延伸 tenapanor 策略的一個例子;其中包括我們近期宣布、已在《橘皮書》(Orange Book)登錄的 2,099 號專利,涵蓋 IBSRELA 與 XPHOZAH 的商業化配方,為這些產品線建立更多價值。
Also included in our pipeline is our development program for our next-generation NHE3 inhibitor, 531, which continues to progress through IND-enabling studies, building on our foundational experience in NHE3 inhibition, and 531 may extend our reach into other therapeutic areas, which would be driving additional value for shareholders.
我們研發管線亦包含下一代 NHE3 抑制劑 531 的開發計畫;該計畫持續推進至 IND 申請前的支持性研究(IND-enabling studies),並建立在我們於 NHE3 抑制領域的基礎經驗之上。531 也可能讓我們延伸至其他治療領域,進而為股東創造額外價值。
We're excited for the next phase of Ardelyx evolution as we execute on our pipeline and explore various external opportunities that align with our mission and core capabilities and meet our disciplined capital allocation approach.
隨著我們推進研發管線並探索各種外部機會(符合我們的使命與核心能力,且符合我們嚴謹的資本配置方法),我們對 Ardelyx 演進的下一階段感到振奮。
We've been growing our team at Ardelyx and now have a deep bench of talent at the executive level. I'm excited with the two newest additions who have joined the executive team, Felicia Ettenberg, our Chief Legal Officer; and Dr. Rajani Dinavahi, our Chief Medical Officer. Felicia's broad legal training and experience as a business partner, as well as Rajani's experience in advancing innovative therapies from development to patients will be beneficial to Ardelyx as we build upon our commercial foundation, invested on pipeline and focus on delivering meaningful outcomes for patients.
我們持續擴充 Ardelyx 團隊,目前在高階主管層級已具備深厚的人才梯隊。我也很高興兩位最新加入執行團隊的成員:法務長 Felicia Ettenberg,以及醫學長 Rajani Dinavahi 醫師。Felicia 廣泛的法律訓練與作為業務夥伴的經驗,以及 Rajani 將創新療法從研發推進至患者端的經歷,將有助於 Ardelyx 在既有商業基礎上持續發展、投資研發管線,並專注於為患者帶來具意義的成果。
I'd also like to take a moment to thank Dr. Laura Williams, our Chief Patient Officer, who's been serving the dual role of CMO and CPO, while helping to guide us on this journey and has done an outstanding job advancing our clinical programs. Thank you, Laura.
我也想藉此機會感謝 Laura Williams 醫師(我們的首席患者官,Chief Patient Officer)。她在擔任 CPO 的同時,也兼任醫學長(CMO),在引導我們前進的過程中發揮關鍵作用,並在推進我們的臨床計畫方面表現卓越。謝謝你,Laura。
Finally, we remain in a position of financial strength. Our Q1 revenue performance positioned us to reiterate. Our previously communicated full-year 2026 revenue guidance for IBSRELA and XPHOZAH, we have the flexibility to allocate capital to both near-term commercial execution and investments that will expand our pipeline to drive long-term growth value for the company, our patients, and our shareholders.
最後,我們仍維持強健的財務狀況。我們第一季的營收表現使我們得以重申先前所溝通的 2026 全年 IBSRELA 與 XPHOZAH 營收指引。我們也具備彈性,可將資本配置於短期的商業執行,以及能擴展研發管線、推動公司長期成長價值的投資,為公司、患者與股東創造價值。
I'm confident in our strategy and our team's ability to deliver on our key priorities. Together, we are advancing a growing, differentiated, innovative pipeline of medicines that address unmet patient needs.
我對我們的策略以及團隊達成關鍵優先事項的能力充滿信心。我們正共同推進一條持續成長、具差異化且創新的藥物研發管線,以滿足患者尚未被滿足的需求。
And with that, I'm pleased to turn the call over to Eric to walk you through our commercial success. Eric?
接下來,我很高興把電話交給 Eric,請他帶各位了解我們的商業成功。Eric?
Eric Foster - Chief Commercial Officer
Eric Foster - Chief Commercial Officer
Thank you, Mike. It's great to be with you all again. In Q1, we continued to build upon the incredible commercial momentum and execution and performance from last year. IBSRELA grew in total riders, new and refilled prescriptions, and total prescriptions year-over-year. For XPHOZAH, we continued to ensure patient access regardless of payer coverage, which drove an increase in total dispenses and paid prescriptions year-over-year.
謝謝你,Mike。很高興再次與各位相聚。第一季,我們延續並強化去年令人振奮的商業動能、執行力與表現。IBSRELA 在總用藥人數、新增與續配處方,以及總處方量方面皆呈現年增。XPHOZAH 方面,我們持續確保患者不受付款方給付限制仍可取得藥物,帶動總配藥量與自付/已付費處方(paid prescriptions)年增。
Our commercial team remains focused on expanding adoption among HCPs, creating greater brand awareness for patients and ensuring the fulfillment of written prescriptions. Our investments to improve the HCP and patient journey and expand access to our medicines have turned into consistent year-over-year growth for both IBSRELA and XPHOZAH.
我們的商業團隊仍聚焦於擴大醫療專業人員(HCP)的採用、提升患者對品牌的認知,並確保已開立處方能順利完成配藥。我們在改善 HCP 與患者旅程、以及擴大藥物可近性方面的投資,已轉化為 IBSRELA 與 XPHOZAH 兩者穩定的年增成長。
Let me start with IBSRELA. IBSRELA continues to be our main revenue driver, and our commercial execution generated 58% product revenue growth year-over-year. During the quarter, we saw robust demand trends, notwithstanding expected first-quarter market dynamics and temporary disruption from two severe winter storms.
我先從 IBSRELA 談起。IBSRELA 仍是我們主要的營收驅動來源,而我們的商業執行帶來產品營收年增 58%。本季我們觀察到強勁的需求趨勢,儘管存在預期中的第一季市場動態,以及兩場嚴重冬季風暴造成的短暫干擾。
Our growth in demand is a result of our efforts to capture more of the IBS-C market in 2026 by driving IBSRELA as the first-line therapy following a secretagogue failure. IBSRELA is a first-in-class, innovative medicine with a winning and sustainable physician in a growing market with nearly 7 million prescriptions written last year.
需求成長來自我們在 2026 年爭取更多 IBS-C 市場份額的努力:在促分泌劑治療失敗後,推動 IBSRELA 作為第一線治療。IBSRELA 是同類首創(first-in-class)的創新藥物,在一個持續成長、且去年處方量接近 700 萬張的市場中,具備強勁且可持續的醫師採用動能。
Through research, we know that as many as 77% of patients on secretagogue continue to experience symptoms despite treatment, demonstrating a high unmet medical need for additional options.
透過研究我們得知,使用促分泌劑的患者中,多達 77% 即使接受治療仍持續出現症狀,顯示對於額外治療選項存在高度未被滿足的醫療需求。
I'll now walk you through our key demand drivers, which include growing both breadth and depth of writing. Increasing patient activation, and lastly, improving prescription pull-through and fulfillment.
我現在將帶您了解我們的關鍵需求驅動因素,包括同時提升處方覆蓋廣度與深度、提高病患主動參與度,最後是改善處方拉動(pull-through)與配藥履約(fulfillment)。
Beginning with growing breadth and depth of riding, we are focusing on high-riding healthcare providers who are responsible for approximately 50% of the IBS-C total prescriptions, and our field sales team is driving greater reach across those targets.
首先談到提升處方覆蓋的廣度與深度,我們聚焦於高處方量的醫療照護提供者(HCP),他們約占 IBS-C 總處方量的 50%,而我們的外勤銷售團隊正推動在這些目標客群中的觸及率提升。
These efforts resulted in an increase in the number of riders in Q1, underscoring the effectiveness of our commercial activities. We are also seeing deeper prescribing within existing accounts.
這些努力使第一季(Q1)的開方醫師數增加,凸顯我們商業活動的有效性。我們也看到既有客戶帳戶內的處方深度提升。
When an HCP is familiar with the access path and sees positive patient experiences, they are more likely to prescribe IBSRELA more broadly. Our end-market messaging focused on IBSRELA's differentiated mechanism of action and its established safety and efficacy profile is resonating and continuing to drive HCPs to prescribe IBSRELA.
當 HCP 熟悉給付取得(access)路徑並看到正向的病患使用體驗時,他們更可能更廣泛地開立 IBSRELA。我們面向終端市場的訊息傳遞聚焦於 IBSRELA 具差異化的作用機轉,以及其已建立的安全性與有效性特徵,這些訊息正在引起共鳴,並持續推動 HCP 開立 IBSRELA。
With respect to patients, the IBS-C population is highly engaged in managing their condition. As awareness of IBSRELA's effectiveness and safety increases, patients are more likely to initiate conversations with their physicians, which in most cases results in a prescription.
就病患而言,IBS-C 族群在管理自身病況方面高度投入。隨著對 IBSRELA 有效性與安全性的認知提升,病患更可能主動與醫師展開對話,而多數情況下會促成處方。
We continue to focus on identifying and reaching patients through multifaceted marketing efforts. We are currently seeing robust engagement across digital and social channels, while we continue to explore new channels to reach and engage with the sizable IBS-C patient population looking for something different.
我們持續透過多面向的行銷努力,聚焦於辨識並觸及病患。目前我們在數位與社群渠道看到強勁的互動參與,同時也持續探索新渠道,以觸及並吸引規模可觀、尋求不同選擇的 IBS-C 病患族群。
One such initiative is through our partnership with the LPGA, where we will educate, empower, and mobilize patients to take control of their IBS-C by seeking new information and talking to their doctor about their symptoms and the treatment options that are available. We chose to partner with the LPGA due to their clear strategic alignment between the LPGA's legacy of empowering women and our deluxe mission to empower patients to proactively manage their health.
其中一項倡議是與 LPGA 的合作,我們將透過教育、賦能並動員病患,讓他們藉由尋求新資訊、與醫師討論症狀及可用治療選項,來掌握並管理其 IBS-C。我們選擇與 LPGA 合作,是因為 LPGA 長期以來賦能女性的傳承,與我們的 deluxe 使命——賦能病患主動管理健康——在策略上高度一致。
Patients deserve open dialogue about their symptoms and their options, and we are excited to partner with the LPGA to accomplish this goal.
病患值得就其症狀與選項進行開放對話,我們很高興能與 LPGA 合作以達成此目標。
Lastly, our full commercial organization is focused on driving prescription pull-through to help ensure that all patients prescribed IBSRELA get on treatment. Based on prior success, we are increasing the presence of our field reimbursement managers who support patient access. This team is talking directly to prescribers and supporting them with account education and patient pull-through to improve patient access.
最後,我們完整的商業組織聚焦於推動處方拉動(pull-through),以協助確保所有被開立 IBSRELA 的病患都能開始並持續治療。基於先前的成功經驗,我們正提高外勤給付報銷經理(field reimbursement managers)的配置,以支援病患取得用藥。該團隊直接與開方者溝通,並透過帳戶教育與病患拉動支援來改善病患可近性。
To drive further adoption, we are continuing to encourage HCPs to send prescriptions to the IBSRELA Pharmacy Network, a limited group of specialty pharmacies that offer a patient-centric, high-touch experience and who are best equipped to handle prior authorizations and to payer hurdles that can restrict patient access. As prescriptions go through our specialty pharmacy network, fulfillment rates are higher, and we see, on average, an additional. Per year for patients. This is a high-value opportunity that we will continue to help achieve our projected revenue growth.
為了進一步推動採用,我們持續鼓勵 HCP 將處方送至 IBSRELA 藥局網絡(IBSRELA Pharmacy Network)——這是一小部分專科藥局,能提供以病患為中心的高接觸服務,且最能處理事前授權(prior authorizations)與可能限制病患取得用藥的付款方障礙。當處方透過我們的專科藥局網絡流轉時,配藥履約率更高,而且我們平均看到每位病患每年額外增加……。這是一個高價值機會,我們將持續推進,以協助達成我們預期的營收成長。
We are united in our purpose to make a meaningful difference to patients impacted by IBS-C, and we are moving with urgency to capture the opportunities ahead and realize our full potential.
我們以共同使命團結一致,致力於為受 IBS-C 影響的病患帶來有意義的改變;我們也以緊迫感把握眼前機會,實現我們的全部潛力。
Moving on to XPHOZAH. Our high-performing, patient-focused XPHOZAH team is committed to achieving the full potential of XPHOZAH and bringing this important medicine to patients in need. I continue to be proud of the team's ability to improve patient access and drive growth. As a result, we saw an increase in total dispenses by 32% and paid prescriptions by 19% compared to the same quarter in 2025, which is important as the overall prescription market declined by 10% over the same time period.
接著談 XPHOZAH。我們高績效、以病患為中心的 XPHOZAH 團隊致力於充分釋放 XPHOZAH 的潛力,並將這項重要藥物帶給有需求的病患。我持續為團隊改善病患可近性並推動成長的能力感到自豪。因此,與 2025 年同季相比,我們看到總配藥量(total dispenses)增加 32%,付費處方(paid prescriptions)增加 19%;而在同一期間,整體處方市場下滑了 10%,這點尤其重要。
We are broadening our reach by employing targeted sales initiatives and a cross-channel strategy to increase HCP and patient engagement. We saw solid growth across key metrics in Q1 with notable increases in total riders, new and refill prescriptions and total prescriptions across the non-medicare segments compared to the same time period last year. This growth shows progress against our key strategic initiatives, which includes optimized HCP targeting and enhanced access messaging to support pull-through.
我們透過精準的銷售倡議與跨渠道策略擴大觸及,以提升 HCP 與病患的互動參與。第一季在關鍵指標上呈現穩健成長,與去年同期相比,在非 Medicare 族群中,總開方者數、新處方與續配處方,以及總處方量均有顯著增加。這些成長顯示我們在關鍵策略倡議上取得進展,包括最佳化 HCP 目標鎖定,以及強化可近性訊息以支援處方拉動(pull-through)。
XPHOZAH continues to be an important contributor for our deluxe, and we remain focused on supporting and ensuring access for all patients regardless of payer coverage. With the majority of patients treated with binders not having fully controlled phosphorus, the high unmet need is clear.
XPHOZAH 持續是我們 deluxe 的重要貢獻者,我們仍專注於支援並確保所有病患不論付款方給付情況皆能取得用藥。由於多數使用磷結合劑(binders)治療的病患其磷控制仍未達標,顯示高度未被滿足的需求十分明確。
I'm confident in the team's ability to deliver on our priorities for both IBSRELA and XPHOZAH this year. The entire organization is executing incredibly well at a high level in a fast-paced environment, consistently achieving our shared goals as a result. At the same time, we are making prudent investments across the commercial organization to strengthen our position in the market, support patients along their journey, and accelerate long-term growth. I will now turn it over to Sue. Sue?
我對團隊今年在 IBSRELA 與 XPHOZAH 兩項產品上達成優先事項的能力充滿信心。整個組織在快速變動的環境中以高水準執行,並因此持續達成我們共同的目標。同時,我們也在商業組織中進行審慎投資,以強化市場地位、在病患旅程中提供支持,並加速長期成長。接下來我把時間交給 Sue。Sue?
Susan Hohenleitner - Chief Financial Officer
Susan Hohenleitner - Chief Financial Officer
As you heard from Mike and Eric, we are continuing to advance our commercial momentum to drive significant value creation. We are leveraging disciplined capital allocation into a clear strategic advantage by investing with purpose and commercial growth and building our pipeline.
正如您從 Mike 與 Eric 那裡聽到的,我們持續推進商業動能,以創造顯著的價值。我們以有紀律的資本配置形成清晰的策略優勢——以明確目的投入於商業成長並建構我們的研發管線。
We are driving towards profitability and meaningful cash generation, allowing us to strengthen our balance sheet, invest in growth, and build long-term shareholder value.
我們正朝向獲利與具意義的現金創造邁進,使我們得以強化資產負債表、投資成長,並建立長期股東價值。
Now let me walk you through the financials. Our quarter-over-quarter total product revenues were $93.4 million compared to $67.8 million in the same period last year, representing 38% growth. That growth was driven by a significant increase in IBSRELA demands with Q1 2026 revenues of $70.1 million, an increase of 58% compared to Q1 of 2025.
接下來我將帶您看財務數據。我們本季產品總營收為 9,340 萬美元,去年同期為 6,780 萬美元,年增 38%。此成長主要由 IBSRELA 需求大幅增加所帶動,2026 年第一季 IBSRELA 營收為 7,010 萬美元,較 2025 年第一季成長 58%。
The Q1 2026 demand for IBSRELA increased despite the expected Q1 seasonal dynamics that were further exacerbated by the winter storm. We continue to expect IBSRELA revenues to grow quarter-over-quarter for the remainder of the year.
2026 年第一季 IBSRELA 的需求增加,儘管存在預期中的第一季季節性因素,且冬季風暴使其影響進一步加劇。我們仍預期 IBSRELA 營收在今年剩餘期間將逐季成長。
Revenue for XPHOZAH during the first quarter of 2026 was $23.3 million and on an as-reported basis remained consistent with the prior year revenue. However, it's important to understand the underlying business results we're seeing.
2026 年第一季 XPHOZAH 營收為 2,330 萬美元,按申報口徑(as-reported basis)與前一年營收持平。然而,理解我們所看到的底層業務結果很重要。
As you may recall, in Q1 2025, we recorded a $3.8 million favorable adjustment related to product returns. Taking that adjustment into account, our paid prescriptions of XPHOZAH revenue actually grew 19% year-over-year.
您可能記得,在 2025 年第一季,我們記錄了一筆 380 萬美元的有利調整,與產品退貨(product returns)相關。將該調整納入考量後,XPHOZAH 的付費處方所帶來的營收實際上年增 19%。
Now turning to expenses. R&D expenses for the first quarter of 2026 were $20.2 million compared to $14.9 million for the same period in 2025. This increase primarily reflects development activities for the ACCEL Phase 3 trial for CIC. SG&A expenses were $102.3 million for the first quarter of 2026 compared to $83.2 million for the same period in 2025. This increase was reflective of the ongoing investments to drive commercialization demand and adoption of IBSRELA.
接著看費用。2026 年第一季研發(R&D)費用為 2,020 萬美元,較 2025 年同期的 1,490 萬美元增加。此增幅主要反映 CIC 的 ACCEL 第三期(Phase 3)試驗之開發活動。2026 年第一季銷售、一般及行政(SG&A)費用為 1.023 億美元,較 2025 年同期的 8,320 萬美元增加。此增幅反映我們持續投入以推動 IBSRELA 商業化需求與採用。
Our net loss for the first quarter of 2026 was $37.6 million or a loss of $0.15 per share compared to a net loss of $41.1 million or $0.17 per share for the same period in 2025. The net loss for Q1 2026 included $14.2 million for non-cash expenses from share-based compensation compared to $12.1 million for the same period in 2025.
2026 年第一季淨損為 3,760 萬美元,或每股虧損 0.15 美元;相較之下,2025 年同期淨損為 4,110 萬美元,或每股虧損 0.17 美元。2026 年第一季淨損包含 1,420 萬美元的非現金費用(來自股份基礎給付),而 2025 年同期為 1,210 萬美元。
We are in a position of financial strength with $238.1 million in total cash, cash equivalents and short-term investments as of the end of the first quarter.
截至第一季末,我們的財務狀況穩健,現金、約當現金與短期投資合計為 2.381 億美元。
To capitalize on the favorable market conditions, we recently refinanced our existing debt with SLR. You may recall we entered into a loan agreement with SLR in 2022 that provided a total of $300 million of cash, which $200 million has been drawn down. The remaining $100 million of cash is available for drawdown this year.
為把握有利的市場條件,我們近期與 SLR 對既有債務進行再融資。您可能記得,我們在 2022 年與 SLR 簽訂貸款協議,提供總額 3 億美元的資金,其中已動用 2 億美元。剩餘 1 億美元資金可於今年提用。
We are pleased with the positive outcome of this refinancing with SLR, which extended the maturity and interest-only period of our loan by two years and lowered our overall cost of capital and annual interest expenses throughout the term of the loan.
我們對此次與 SLR 再融資的正面成果感到滿意:貸款到期日與僅付利息期間均延長兩年,並降低了我們整體資本成本以及貸款期間內的年度利息費用。
Now turning to guidance for 2026. We are reiterating our 2026 revenue guidance for IBSRELA between $410 million and $430 million. That represents a 50% to 57% year-over-year growth. We expect the growth to be driven by quarter-over-quarter increases in demand, along with improved prescription pull-through. Our long-term growth expectation for IBSRELA remains to reach at least $1 billion in 2029, representing a 38% CAGR.
接著是 2026 年財測指引。我們重申 IBSRELA 2026 年營收指引為 4.10 億至 4.30 億美元,代表年增 50% 至 57%。我們預期成長將由需求逐季增加以及處方拉動(pull-through)改善所驅動。我們對 IBSRELA 的長期成長預期仍為在 2029 年達到至少 10 億美元,代表 38% 的年複合成長率(CAGR)。
Now turning to XPHOZAH. We are reiterating our revenue guidance between $110 million on $120 million in 2026. We continue to invest at an appropriate level to ensure that XPHOZAH remains a contributor of financial growth for our delegates.
現在轉到 XPHOZAH。我們重申 2026 年營收指引為 1.10 億美元至 1.20 億美元。我們將持續以適當的投資水準,確保 XPHOZAH 仍能為我們的代表帶來財務成長的貢獻。
Our full-year product revenues are expected to grow between 38% and 46%, outpacing our operational expenses, which will grow by approximately 25%, consistent with prior guidance. We are at a stage in our development where it's necessary for us to prudently invest in our growth accelerators, our commercial operations, and our pipeline, all of which require high-impact investments in R&D and SG&A.
我們預期全年產品營收將成長 38% 至 46%,增速將超過我們的營運費用;營運費用預計約成長 25%,與先前指引一致。我們目前的發展階段需要審慎投資於成長加速器、商業營運以及研發管線;這些都需要在研發(R&D)與銷售、一般及行政費用(SG&A)上進行高影響力的投入。
In 2025, we grew our cash balance year-over-year even as we increased investment in both commercial execution and pipeline development. As we transition into more steady and measurable cash flow positivity in the near future, I think it's important to begin to share our capital allocation priorities as we head into this new era.
2025 年,即使我們加大對商業執行與管線開發的投資,我們的現金餘額仍較去年同期增加。隨著我們在不久的將來邁向更穩定且可衡量的正向現金流,我認為在進入這個新時代之際,開始分享我們的資本配置優先順序很重要。
Our priorities include, one, accelerating IBSRELA growth as this is our highest ROI use of capital today; two, investing in our current pipeline to create additional growth drivers and expand with external business development opportunities; and three, maintain our financial strength.
我們的優先事項包括:第一,加速 IBSRELA 的成長,因為這是我們目前資本運用中投資報酬率(ROI)最高的用途;第二,投資現有研發管線,以創造額外的成長動能,並透過外部商務開發(BD)機會擴張;第三,維持我們的財務實力。
Importantly, we are funding current operations and pipeline from our revenue base, which demonstrates the growing financial maturity of our deluxe. In addition, as I stated previously, we have proactively refinanced our debt and reduced our cost of capital while preserving optionality for BD partnerships or other future opportunities. Ultimately, all of this builds towards sustainable profitability.
重要的是,我們以營收基礎來支應目前營運與研發管線,這展現了我們業務日益成熟的財務能力。此外,如我先前所述,我們已主動進行債務再融資,在保留與 BD 合作夥伴關係或其他未來機會之選擇權的同時,降低資本成本。最終,這一切都將導向可持續的獲利能力。
We hope this view of our capital allocation priorities is helpful as you continue to support the strategic value of Ardelyx now and as we evolve into the future.
我們希望這份對資本配置優先順序的觀點,能在您持續支持 Ardelyx 的策略價值、以及我們邁向未來演進的過程中有所助益。
With that, I'll hand it back to Mike.
接下來我把時間交還給 Mike。
Michael Raab - President, Chief Executive Officer, Director
Michael Raab - President, Chief Executive Officer, Director
And thank you, Sue. As you heard, we're focused on executing our priorities, significantly drug, IBSRELA, maintain expose and momentum, further advance our pipeline, and continue delivering strong financial results. We are moving with purpose, urgency, and discipline against these priorities, and we look forward to demonstrating continued progress as the year unfolds.
謝謝你,Sue。如各位所聽到的,我們專注於落實我們的優先事項:大幅推動 IBSRELA、維持曝光度與動能、進一步推進研發管線,並持續交出強勁的財務成果。我們以明確目標、緊迫感與紀律推進這些優先事項,並期待在今年接下來的進程中展現持續的進展。
To our investors, employees, and especially the patients, thank you for your continued engagement and support. We're encouraged by the progress we've made and excited about the opportunities ahead. We remain focused on discipline execution, long-term value creation, and we appreciate your continued confidence as we move forward.
致我們的投資人、員工,尤其是病患,感謝各位持續的參與與支持。我們對已取得的進展感到鼓舞,也對前方的機會感到振奮。我們將持續專注於有紀律的執行、長期價值創造,並感謝各位在我們前進過程中持續的信心。
And with that, we'll open the call for questions. Operator?
接下來我們開放提問。接線員?
Operator
Operator
(Operator Instructions) Roanna Ruiz, Leerink Partners.
(接線員指示)Leerink Partners 的 Roanna Ruiz。
Roanna Ruiz - Analyst
Roanna Ruiz - Analyst
Yes, thanks. A couple from me. First one, I thought it was interesting you mentioned that IBSRELA demand increased despite the storms and seasonality. How should that flow through to the next quarters and in light of your current guidance?
是的,謝謝。我有兩個問題。第一個,我覺得你們提到 IBSRELA 的需求在風暴與季節性因素下仍然增加,這點很有意思。這應該如何反映到接下來幾季,以及在你們目前指引的脈絡下該怎麼看?
Michael Raab - President, Chief Executive Officer, Director
Michael Raab - President, Chief Executive Officer, Director
Sure. I'll ask Eric to comment a bit on it. But for us, seeing what we all went through in the first quarter, which is normal seasonality in those two storms, seeing that continued growth in demand only strengthens our conviction in terms of where we're seeing this business grow and very pleased with those results. Eric, anything to add?
當然。我先請 Eric 稍微評論一下。不過對我們而言,回顧第一季大家所經歷的情況——包括正常的季節性以及兩場風暴——在那樣的背景下仍看到需求持續成長,只會更強化我們對業務成長方向的信心,也對這些結果非常滿意。Eric,你要補充嗎?
Eric Foster - Chief Commercial Officer
Eric Foster - Chief Commercial Officer
Yeah, thanks, Roanna, for the question. Very pleased with what we saw in terms of demand in Q1 and very similar to the patterns that we've seen in the past. We expect to continue to see quarter-over-quarter growth as we move forward. I feel very. With the team that we have in place and continuing to invest in access and making sure that all patients that are written a prescription can get fulfillment.
好的,謝謝 Roanna 的提問。我們對第一季看到的需求表現非常滿意,且與我們過去看到的型態非常相似。隨著我們往前推進,我們預期仍會看到逐季成長。我對目前的團隊配置以及我們持續投資於可近性(access)、並確保所有開立處方的病患都能完成取藥(fulfillment)這件事,感到非常有信心。
So I'm still very comfortable about the strategy that we have in place and our ability to be able to continue the strong execution, and you should see that continue to grow as we move through the year.
因此,我仍然非常認同我們目前的策略,以及我們持續強力執行的能力;隨著今年進行,你們應該會看到它持續成長。
Roanna Ruiz - Analyst
Roanna Ruiz - Analyst
Great. And the other question I had, I was curious about any color you could share about OpEx throughout the 2026? How should we think about this with the Phase 3 CIC study ramping up as well?
很好。另一個問題是,我想了解你們能否分享一些 2026 年營運費用(OpEx)的細節?另外,隨著第 3 期 CIC 研究加速推進,我們應該如何看待這件事?
Susan Hohenleitner - Chief Financial Officer
Susan Hohenleitner - Chief Financial Officer
Yeah, thanks, Roanna. Yeah, I would say that we've said before we're going to guide and we are up to about 520 in total OpEx, and that would be consistent throughout the quarters. So we saw in first quarter that we recorded about $122 million of that OpEx expense. So what I would see is a bit of a ramp-up then as we move through.
好的,謝謝 Roanna。是的,我會說我們之前已提過,我們會提供指引,而我們的總營運費用(OpEx)大約是 5.20 億美元,且各季大致一致。因此在第一季,我們認列了約 1.22 億美元的 OpEx 費用。接下來我預期會在往後推進時出現一些爬升。
And yeah, as we continue to enroll the patients in the study, you will see more of those expenses come through the rest of the year.
而且,隨著我們持續在研究中納入病患,你會看到更多相關費用在今年剩餘期間反映出來。
Michael Raab - President, Chief Executive Officer, Director
Michael Raab - President, Chief Executive Officer, Director
And then to be clear, that was all factored into the guidance that we gave, the expectation of the spend that we would have on CIC.
另外要說清楚的是,這些都已納入我們所給出的指引之中,包括我們在 CIC 上預期的支出。
Roanna Ruiz - Analyst
Roanna Ruiz - Analyst
Understood. Thanks a lot.
了解。非常感謝。
Michael Raab - President, Chief Executive Officer, Director
Michael Raab - President, Chief Executive Officer, Director
Thanks, Roanna.
謝謝你,Roanna。
Operator
Operator
Yigal, Citi.
Citi 的 Yigal。
Joohwan Kim - Analyst
Joohwan Kim - Analyst
Hi, this is Joohwan Kim on for Yigal. Congrats on the progress, and thanks for taking our question. Maybe just a quick one from us. Have you tracked toward your December enrollment completion target for the Phase 3 CIC trial? Can you provide any color on the pace of enrollment relative to internal expectations so far, and are there any learnings from the IBS-C [tempo] enrollment experience that are helping you optimize recruitment?
嗨,我是代替 Yigal 的 Joohwan Kim。恭喜你們的進展,也謝謝你們回答我們的問題。我們這邊可能就一個簡短問題:你們是否仍朝著第 3 期 CIC 試驗在 12 月完成收案的目標前進?能否分享目前收案速度相對於內部預期的情況,以及是否有任何來自 IBS-C [tempo] 收案經驗的學習,正在幫助你們優化招募?
Michael Raab - President, Chief Executive Officer, Director
Michael Raab - President, Chief Executive Officer, Director
An interesting question with regards to tempo. As I stated in my comments that we have all the preconceived sites up and running, right, and that pace of enrollment of the sites was wonderful to see and it was on par with what we expected out of the tempo program.
關於 tempo 的確是個有趣的問題。如我在評論中提到的,我們已讓所有預先規劃的試驗中心啟動並運作,且試驗中心啟動的收案節奏很令人欣喜,與我們對 tempo 計畫的預期一致。
As I also noted, the enthusiasm both by treating physicians and patients is evident. And that enrollment continues at pace. So we're very confident with the timeframe that we have shared where we'd be able to expect both for it to be completed and the data to be shared.
另外我也提到,無論是治療醫師或病患的熱忱都很明顯,而收案也持續以既定速度進行。因此,我們對先前分享的時程非常有信心,預期能如期完成,並分享數據。
Joohwan Kim - Analyst
Joohwan Kim - Analyst
Great. Appreciate it.
很好,感謝。
Michael Raab - President, Chief Executive Officer, Director
Michael Raab - President, Chief Executive Officer, Director
Thank you.
謝謝。
Operator
Operator
Dennis Ding, Jefferies & Company.
Jefferies & Company 的 Dennis Ding。
Dennis Ding - Analyst
Dennis Ding - Analyst
Hey, guys. Thanks for taking my questions. I had several questions around IBSRELA. So number one, so Q1 has some seasonality, and on a quarter-over-quarter basis, it was a bigger step down relative to last year, which is totally fine because it's a bigger base. But in terms of the recovery, should we also expect a bigger recovery than what we saw last year as well? I believe consensus for Q2 assumes about like a $30 million quarter-over-quarter recovery for Q2.
嗨,各位。謝謝回答我的問題。我有幾個關於 IBSRELA 的問題。第一,第一季有一些季節性因素,按季比較(quarter-over-quarter)下滑幅度比去年更大,這完全可以理解,因為基期更大。但就回升而言,我們是否也應該預期會比去年看到更大的回升?我相信市場共識對第二季的假設大概是第二季較第一季按季回升約 3,000 萬美元。
Question number two, just specifically around the specialty pharmacy dynamic, can you share if that shift away from retail is working out in terms of better fill and reauthorization relative to last year? The channel is around 30% of the mix, but how much higher can that go? And then I have one more follow-up.
第二個問題,特別是關於專科藥局(specialty pharmacy)的動態,你們能否分享相較去年,從零售端轉移出去是否在更好的配藥完成率(fill)與再授權(reauthorization)方面奏效?該通路約占組合的 30%,但最高可能提升到多少?我還有一個追問。
Michael Raab - President, Chief Executive Officer, Director
Michael Raab - President, Chief Executive Officer, Director
All right. Let me just quickly address some of those and I'll ask Eric to comment. I think the Q2 recovery -- I think, rather than recovery, it's just the normal course of business.
好,我先快速回應其中一些,然後請 Eric 補充。我認為第二季的回升——我想與其說是回升,不如說是正常的業務走勢。
And I think that term is an important one to think about is what we expect and what we plan for, given the predicted and expected dynamics that everyone sees in Q1. Now, the surprise was the storm, the two storms, both the Mid-Atlantic one and the one in the Northeast. And that clearly had a meaningful impact in that sector of the country. And if you think about where many distribution centers are, they were smack dab in the middle of Ohio River Valley, where. That was hit.
我認為這個用詞很重要:我們所預期、也會據以規劃的,是大家在第一季都會看到的可預測、可預期的動態。意外的是風暴——兩場風暴,一場在中大西洋地區,另一場在東北部——這顯然對該區域造成了顯著影響。再想想許多配送中心的位置,它們正好位於俄亥俄河谷的核心地帶,而那裡受到衝擊。
So one can't predict. We're not weather people, and they are wrong 50% of the time, at least. So we don't try to predict storms, but it is one thing that's notable. I'm very confident with the data that you show every week that we're on the path to what we expected out of Q2. I do think, again, just to reemphasize, it's not a recovery, rather just a pattern of the business.
所以有些事無法預測。我們不是氣象專家,而他們至少有 50% 的時間也會出錯。因此我們不嘗試預測風暴,但這確實是一個值得注意的因素。我對你們每週看到的數據非常有信心,我們正走在符合第二季預期的軌道上。我再次強調,這不是回升,而是業務型態的正常表現。
I'll ask Eric to comment a little bit more on that in terms of what they saw in the field. But, the IPN in IBSRELA Pharmacy Network is a fundamental important part of our strategy moving forward, given Eric's comments and his opening statements, it is better for patients.
我會請 Eric 再多談一些他們在第一線看到的情況。不過,IBSRELA 的 IPN(IBSRELA Pharmacy Network,藥局網路)是我們未來策略中一個根本且重要的部分;如同 Eric 的評論與開場所說,這對病患更好。
And I'll let him talk about the dynamics in terms of the shift. And I think at this point, it's early for us to say what we think the ultimate potential or percentage of the business that would go through that. It's probably a little bit too much detail. That will become evident through the data that we know is imperfect, but that will become evident overtime. Eric?
我會讓他談談轉移的動態。至於最終的潛力或會有多少比例的業務會透過該通路進行,我認為現在要下結論還太早,可能也過於細節。這會隨著我們掌握的數據——雖然不完美——在時間推移中逐步變得明朗。Eric?
Eric Foster - Chief Commercial Officer
Eric Foster - Chief Commercial Officer
Yeah, thanks, Mike, and thanks for the question, Dennis. As far as Q1 goes, we had talked about the seasonality. And as Mike said, for us, we've got the experience and the knowledge to know most of that is coming. What we were not aware of, obviously, were the storm. So we feel like the team planned accordingly. We were able to push through the temporary disruption there.
是的,謝謝你,Mike,也謝謝你的提問,Dennis。就第一季而言,我們先前談過季節性。如同 Mike 所說,對我們來說,我們有經驗也有知識,知道大部分情況都會如期發生。當然,我們沒有預料到的是風暴。所以我們覺得團隊已做了相應規劃,也成功挺過了那段短暫的干擾。
And just like we saw last year, we really started to see the acceleration in the back half of the quarter, and we certainly see that, which gives us great confidence as we moved into Q2.
而且就像我們去年看到的一樣,我們確實在本季後半段開始看到加速成長,我們也明確看到了這點,這讓我們在進入第二季時充滿信心。
With regards to the IBSRELA Pharmacy Network, we continue to be very excited about that opportunity and really to bring IBSRELA to patients that are prescribed IBSRELA. So if we think about the fulfillment rate and your question around is there better fulfillment. Absolutely, there is when it goes to the IBSRELA Pharmacy network, and that's really the driver for us to make sure that patients that are prescribed IBSRELA can get access to the treatments.
關於 IBSRELA 藥局網路(IBSRELA Pharmacy Network),我們仍然對這個機會感到非常興奮,因為它能真正把 IBSRELA 帶給被開立 IBSRELA 的病人。若我們從配藥完成率(fulfillment rate)以及你提到是否有更好的完成率來看,答案是絕對有的:當處方透過 IBSRELA 藥局網路時,完成率確實更高。這也是我們推動的核心動因,確保被開立 IBSRELA 的病人能取得治療。
So we'll continue to work on moving business into the IBSRELA Pharmacy network. We expect that to continue through the year. And also, it's important to note, when that happens, there is an additional, on average prescription written -- a refill written in that year. So it's really great for patients. You get a higher fulfillment rate, you get better refill rate as those prescriptions go through the IBSRELA Pharmacy Network.
因此,我們會持續把業務轉移到 IBSRELA 藥局網路中。我們預期這個趨勢會延續全年。另外也很重要的一點是:當這件事發生時,平均而言,當年度每張處方會多出一張額外開立的處方——也就是一次續配(refill)。所以這對病人非常好:處方完成率更高,當處方透過 IBSRELA 藥局網路時,續配率也更好。
Susan Hohenleitner - Chief Financial Officer
Susan Hohenleitner - Chief Financial Officer
The one thing I would add, Dennis, you kind of talked about the guidance. I think we were pretty overt about Q1 with kind of a soft guide, but that was all factored into our full-year and that's all factored into our full-year guidance. But we aren't going to provide similar color. We felt like that was appropriate for Q1 just given the storms and some of the volatility, but I think as go forward, as we said, we're going to continue to grow quarter-over-quarter.
Dennis,我還想補充一點,你提到指引(guidance)。我想我們對第一季其實講得很明白,算是給了一個偏保守的「軟性指引」,但那都已納入我們全年規劃,也都已反映在我們的全年指引之中。不過我們不會提供類似的額外細節。我們覺得就第一季而言,考量風暴與一些波動性,提供那樣的說明是合適的;但往後如我們所說,我們會持續逐季成長。
Dennis Ding - Analyst
Dennis Ding - Analyst
Perfect. And then as my follow-up, so Lilly is running a Phase 2 with its [GIFR Agnes] for IBS-C. Data might be in 2027. So I'm curious how you're thinking about that study and the durability of the IBSRELA franchise over the long-term in the 2030s, and we'll be well north of $1 billion in revenue.
很好。那我的追問是:Lilly 正在針對 IBS-C 進行其 [GIFR Agnes] 的第二期試驗,資料可能在 2027 年出來。我想了解你們如何看待這項研究,以及 IBSRELA 產品線在長期、到 2030 年代的持久性;屆時我們的營收將遠超過 10 億美元。
Michael Raab - President, Chief Executive Officer, Director
Michael Raab - President, Chief Executive Officer, Director
I mean, I think for us, what we need to do is follow the data. And anything that helps patients is the good thing. I think that is just a fundamental way that we and I look at this business. Anything that's going to help patients is the right thing to do. The realities are, if you look at the potential patients that could, should, or might be taking GLP-1, it's a relatively small percentage who actually are versus those who would benefit from it.
我的意思是,對我們而言,我們需要做的是追隨數據(follow the data)。任何能幫助病人的事情都是好事。我認為這是我們、也是我看待這門生意的一個基本原則:任何能幫助病人的事,就是正確的事。現實是,如果你看可能、應該或或許會使用 GLP-1 的潛在病人,其實真正正在使用的人只占相對小的比例,相較於那些會從中受益的人。
So I wouldn't imagine there's going to be a massive degradation of the market given the positioning that we have [Forbes-RELA] in that market. I don't see that as a massive threat on the horizon. Is it better for patients if it works? Of course, it is, and that's something we should cheer.
所以我不認為市場會出現大幅度的侵蝕,考量到我們在該市場中對 [Forbes-RELA] 的定位。我不把它視為地平線上重大的威脅。若它有效,對病人更好嗎?當然是,而這也是我們應該樂見其成的事。
Dennis Ding - Analyst
Dennis Ding - Analyst
Perfect. Thanks so much.
很好。非常感謝。
Michael Raab - President, Chief Executive Officer, Director
Michael Raab - President, Chief Executive Officer, Director
Thanks, Dennis.
謝謝你,Dennis。
Operator
Operator
Chris Raymond, Raymond James.
Chris Raymond,Raymond James。
Christopher Raymond - Analyst
Christopher Raymond - Analyst
Hey, yeah, thanks. So we've talked to some KOLs who indicate they're already using IBSRELA. To some extent in CIC. Mike, I know you're not going to want to give too much color here, but just maybe in broad strokes, can you guys talk maybe about what kind of CIC use you're seeing in the field?
嗨,謝謝。我們和一些 KOL 討論過,他們表示已經在使用 IBSRELA,在某種程度上也用於 CIC。Mike,我知道你可能不想在這裡透露太多細節,但能否大致談談你們在第一線看到的 CIC 使用情況?
I mean, Linzess, Trulance, Amitiza, they all have CIC on their labels already, so maybe the second part of that question is, would the competitive dynamic in this indication be maybe similar to what we've seen with IBS-C, or are you thinking something different? Thanks.
我的意思是,Linzess、Trulance、Amitiza 的標籤上本來就都有 CIC 適應症,所以這個問題的第二部分是:在這個適應症上的競爭態勢,會不會和我們在 IBS-C 看到的情況類似,還是你們有不同的看法?謝謝。
Michael Raab - President, Chief Executive Officer, Director
Michael Raab - President, Chief Executive Officer, Director
So, yes, what's important about what you said is all the others have dual indication. And clearly, we have heard and understand what you've described as well in your KOL clinician discussions. As physicians, in the art of what they practice, can prescribe things off-label. We cannot promote things off-label, and we won't and don't. That is a fundamental part of this business, as everyone understands.
是的,你提到的重點很重要:其他產品都具有雙適應症。而且很明顯地,我們也聽到並理解你在與 KOL 臨床醫師討論中所描述的情況。醫師在其臨床實務的「藝術」中,可以進行適應症外用藥(off-label)處方。我們不能推廣適應症外用途,我們也不會、也沒有這麼做。這是這個產業的基本原則,大家都理解。
If a physician feels it's appropriate for CIC, they should. And what's really interesting, if you haven't looked at Rome [5], which was just published, the changing definition of CIC, functional constipation, IBS-C, which we know, given our experiences on the front lines, is a continuum of care.
如果醫師覺得用於 CIC 是合適的,他們就應該這麼做。更有意思的是,如果你還沒看過剛發布的 Rome [5],它對 CIC、功能性便秘、IBS-C 的定義正在改變;而我們在第一線的經驗也知道,這其實是一個連續性的照護光譜(continuum of care)。
And understanding how the Rome Foundation has evolved, its definitions, is one of the fundamental reasons why we've moved into the CIC program, is it's a natural course. And I think as we've spoken over the years, would we have loved to have had both indications at launch, of course, but as I'm cheap and we didn't have the money to invest in both indications.
理解 Rome Foundation 的定義如何演進,是我們推進 CIC 計畫的根本原因之一,因為這是一個自然的發展路徑。我想這些年我們也談過:我們當然希望在上市時就同時擁有兩個適應症;但坦白說,因為我很節省,而我們當時也沒有資金去同時投資兩個適應症。
And now that we are in a place that we can, we are to provide those benefits and try to eliminate some of the barriers in the way that physicians think about this and the further hurdles that the prior authorizations will put them through if it's an off-label indication.
而現在我們有能力這麼做了,我們就會去做,提供這些效益,並嘗試消除一些障礙——包括醫師在思考這件事時的障礙,以及若是適應症外使用,事前授權(prior authorization)會讓他們面臨更多關卡。
So, I agree with everything that is the genesis of your question, and I think what we're doing with the CIC program is specifically designed to address that, coupled with what's happened with Rome 5.
所以,我同意你這個問題背後的所有出發點;我也認為我們的 CIC 計畫就是為了具體解決這些問題而設計的,同時也結合 Rome 5 所帶來的變化。
Operator
Operator
Thank you.
謝謝。
Michael Raab - President, Chief Executive Officer, Director
Michael Raab - President, Chief Executive Officer, Director
Thanks, Chris.
謝謝你,Chris。
Operator
Operator
Allison Bratzel, Piper Sandler & Company.
Allison Bratzel,Piper Sandler & Company。
Unidentified Participant
Unidentified Participant
Hi, this is Ashley on for Alli. Congrats on the court and all the progress made. So, just two questions from us. You talked about it in your prepared remarks, but could you talk a little more about the IBSRELA pediatric trials and just the workings of the potential six months for the additional patent life and how meaningful those additional six months could be for IBSRELA?
嗨,我是 Ashley,代替 Alli 提問。恭喜你們在訴訟以及各項進展上取得成果。我們有兩個問題:你們在事先準備的講稿中提到過,但能否再多談一些 IBSRELA 的兒科試驗,以及可能額外延長六個月專利期的運作方式?另外,這額外六個月對 IBSRELA 可能有多大的意義?
And then also, just wondering, once the IND is filed, do you have any line of sight into timelines around getting 531 into the clinic, and how quickly do you plan to move if the IND studies are positive? Thank you.
另外也想請教,一旦 IND 送件後,你們是否能掌握 531 進入臨床的時間表?如果 IND 研究結果正向,你們計畫以多快的速度推進?謝謝。
Michael Raab - President, Chief Executive Officer, Director
Michael Raab - President, Chief Executive Officer, Director
We will work at pace if those studies are positive, because it's the right thing to do. But fundamental, again, to what we do is we follow the data. And all this pre-IND work is really critical for us to understand. Remember -- actually, let me remind you that when we created tenapanor back in 2009. It was based upon a huge amount of preclinical work that we had done to understand all aspects of where this molecule engages, certainly with animal models and ultimately into man.
如果那些研究結果是正向的,我們會加速推進,因為那是正確的事。但同樣地,我們工作的根本原則是追隨數據。所有這些 IND 前(pre-IND)的工作,對我們理解非常關鍵。請記得——其實讓我提醒一下:我們在 2009 年創造 tenapanor 時,是建立在大量的臨床前研究之上,用來理解這個分子在各方面的作用位置,當然包括動物模型,並最終走向人體。
So we have good experience in this, and there are very tried and true approaches that one takes in order to make the decision to or not to file an IND, and the data tell us what the right thing is to do.
所以我們在這方面有很好的經驗,也有一些非常成熟、經過驗證的方法來做出是否提交 IND 的決策,而數據會告訴我們什麼才是正確的做法。
With regards to the pediatric indication, this is tried and true practice that everyone does in the industry. One of the things that the FDA put in place was the pediatric act to encourage companies to develop drugs for the pediatric populations. Now, it is pretty hard in IBS-C, given different age groups, the inability or challenge to describe pain. It's subjective.
至於兒科適應症,這是產業中大家都在做、且行之有年的做法。FDA 推出的措施之一是《兒科法案》(pediatric act),用以鼓勵公司為兒科族群開發藥物。不過在 IBS-C 上其實相當困難,因為不同年齡層、以及無法或難以描述疼痛的問題;這是主觀的。
So it's a harder population. It's a smaller population. But the mere operational effort to put this in place, primarily to show safety, is one of the fundamental tenets of pediatric development, is it allows you flexibility to treat the younger patients if you demonstrate the safety that we expect to demonstrate, given our long history of utility of this molecule.
所以這是一個更難的族群,也是更小的族群。但就營運層面而言,把這件事建立起來——主要是為了證明安全性——是兒科開發的基本要件之一;如果你能證明我們預期能證明的安全性(基於我們長期使用這個分子的歷史),就能讓你在治療更年幼病人時有更大的彈性。
So the benefit of that six months, you look at whatever peak it is that you guys have modeled, just look at each incremental month of value that will generate, and that will tell you the value in your modeling of what those six months are worth. It's significant.
至於那六個月的效益,你可以看你們模型中預估的峰值是多少,然後把每增加一個月所能產生的價值算出來,就能在你們的模型中得出那六個月值多少。這是很可觀的。
Unidentified Participant
Unidentified Participant
Got it. Thank you for the color.
了解。謝謝你補充說明。
Operator
Operator
Joseph Thome, TD Cowen.
Joseph Thome,TD Cowen。
Joseph Thome - Analyst
Joseph Thome - Analyst
Hi there. Good afternoon, and thank you for taking my questions. Maybe a little bit of an extension of a prior question, but can you walk through the physician touchpoint differences between CIC and IBS constipation? I guess if you are successful in CIC, would you need to go a little bit more maybe into a primary care segment or anything like that with your sales force, or by the time they're presenting the level of getting IBSRELA maybe in a GI office. Anything around that would be helpful.
你好,午安,謝謝你回答我的問題。這可能算是延伸前面的一個問題,但你們能否說明在 CIC 與 IBS 便秘之間,醫師接觸點(touchpoint)有哪些差異?我想問的是,如果你們在 CIC 上取得成功,你們的銷售團隊是否需要更深入觸及基層醫療(primary care)等族群,或是等到病人呈現到需要 IBSRELA 的程度時,通常就已經在腸胃科(GI)診所了?任何相關說明都會很有幫助。
And then you mentioned that a couple of times, obviously, on the call. Can you talk a little bit about the company's willingness to maybe lever up the balance sheet, given what your expectations are for the growth of IBSRELA to do something maybe a little bit larger in size?
然後你在電話會議上顯然也提到過幾次。鑑於你們對 IBSRELA 成長的預期,能否談談公司是否願意在資產負債表上提高槓桿,以便做一些可能規模更大一點的事情?
Michael Raab - President, Chief Executive Officer, Director
Michael Raab - President, Chief Executive Officer, Director
Sure. Let me address the first one and then ask Eric to comment too is, I think as we said when we announced the ACCEL program is the CIC market is significantly larger than the IBS-C market. However, the vast majority of those patients are effectively treated with over-the-counter medications.
當然。我先回應第一個部分,然後也請 Eric 一起補充。我想正如我們在宣布 ACCEL 計畫時所說,CIC 市場顯著大於 IBS-C 市場。然而,絕大多數這些患者其實透過非處方(OTC)藥物就能得到有效治療。
So I think that's an important distinction as you look at the epi in these populations as to what the differences are and not get over your skis in terms of what that market sizing might be, because it's an important distinction of those that are not served by OTC meds are the ones that end up going and being referred to other offices.
所以我認為,當你看這些族群的流行病學(epi)以及差異時,這是一個重要的區分;不要在市場規模估算上過度樂觀,因為關鍵差別在於:那些無法被 OTC 藥物滿足的患者,才會進一步就醫並被轉介到其他診所。
And Eric, do you want to comment a little bit on what we would do in the field, if anything, differences.
Eric,你要不要也談談我們在第一線會做些什麼(如果有的話),以及有哪些不同?
Eric Foster - Chief Commercial Officer
Eric Foster - Chief Commercial Officer
Yes, thanks, Joe, for the question. So as today, we focus on high-riding GIs, APPs and high-riding non-GIs. So that does put us in more of the primary care setting and feel really confident about the targeting that we have right now for IBS-C, and you can see a lot of the great momentum that we have.
好的,謝謝你,Joe,謝謝這個問題。目前我們聚焦於高處方量的腸胃科醫師(GIs)、APPs,以及高處方量的非腸胃科醫師。這確實讓我們更偏向在基層醫療(primary care)的場域,我們也對目前針對 IBS-C 的目標客群設定非常有信心,你也可以看到我們目前很強的動能。
With regards to CIC, I do think you're correct. As Mike mentioned, it is a bit of a larger patient population, and we do see and expect more patients to be going to their primary care. So at some point, as we are continuing to look at that patient population and making sure that we have the right reach. We'll make that decision at that time, but certainly I can see that there is more utilization in the primary care market. I mean that's something that we definitely will consider as we look at the right sizing of the team as we get closer to product being approved in the market.
至於 CIC,我確實認為你說得對。如 Mike 提到的,這是一個更大的患者族群,我們也看到並預期會有更多患者先去看他們的基層醫療醫師。因此,在某個時間點,當我們持續評估這個患者族群並確保我們有適當的觸及範圍時,我們會在那時做出決策;但我確實可以看到在基層醫療市場會有更高的使用量。我的意思是,當我們在產品更接近獲批上市時,這絕對是我們在評估團隊規模是否合適時會納入考量的事情。
Michael Raab - President, Chief Executive Officer, Director
Michael Raab - President, Chief Executive Officer, Director
And Joe, I think a fundamental part of that is, Eric has talked about this in the past, we call on 50% of the HCPs today that write for IBS-C and frankly CIC indicated drugs alike, and that's the 14,000 HCPs. The other 50% is 182,000 HCPs, and we're not going to cover them all, right? So it's going to be an optimization of those who might be writing disproportionately amount for CIC, which you can find through the data.
Joe,我想其中一個根本點是——Eric 以前也談過——我們目前拜訪的 HCPs 約占今天會開 IBS-C、以及坦白說也會開 CIC 適應症藥物的醫療人員的 50%,也就是 14,000 位 HCPs。另一個 50% 是 182,000 位 HCPs,而我們不可能全部覆蓋,對吧?所以會是最佳化:找出那些在 CIC 上可能開立量特別高的人,這可以透過數據找得到。
But a little bit of a cautionary note, not to take this as though we're going to double or trouble the size of the organization, but rather an optimization as you've seen us do this year.
但也提醒一下,不要把這解讀成我們要把組織規模加倍或增加到三倍;更像是你今年看到我們所做的那樣,去做最佳化。
With regards to levering the balance sheet, it's such an incredible pivotal time for the evolution of the company. We're not really reading between the lines, Sue has said explicitly, we're going to generate more top-line than expense.
至於提高資產負債表槓桿,這對公司演進而言是個非常關鍵的時點。我們並不是在字裡行間解讀——Sue 已經明確說過,我們將產生比費用更多的營收(top-line)。
So that journey that we're on, that horizon is not that far away with what we're trying to do. So I'll ask Sue to comment, I'm not sure how much leverage is needed versus execution in the way we're doing, but certainly we're not afraid of doing the right thing for opportunities that present themselves.
所以我們正在走的這段旅程,那個時間點其實不遠,這也是我們努力要達成的。我請 Sue 來補充——我不確定需要多少槓桿,相較之下更重要的是我們目前的執行方式;但可以肯定的是,若有機會出現,我們不會害怕做正確的事。
Susan Hohenleitner - Chief Financial Officer
Susan Hohenleitner - Chief Financial Officer
Yes, Joe, you heard that we already did you a refinance of our debt. We still have access to an extra $100 million of that loan. So we've got that. We've got plenty of options to do that if and when it's necessary or a great opportunity presents itself.
是的,Joe,你也聽到了,我們已經做了債務再融資。我們仍可額外動用該筆貸款中的 1 億美元。所以我們有這個額度。我們也有很多選項,在必要時或當出現很好的機會時,都可以採取行動。
Operator
Operator
Great. Thank you.
很好。謝謝你。
Michael Raab - President, Chief Executive Officer, Director
Michael Raab - President, Chief Executive Officer, Director
Thanks, Joe.
謝謝你,Joe。
Operator
Operator
Laura Chico, Wedbush Securities.
Laura Chico,Wedbush Securities。
Laura Chico - Analyst
Laura Chico - Analyst
Thank you very much for taking the question. Three from me. First, I thought I heard Eric mention an expansion of the field manager level, and I'm just trying to understand if that's more impactful on the depth of prescribing or the breadth of prescribing, and which of those two levers impacts hitting the upper range of guidance or kind of impacts the guidance swing there. And I have two quick follow-ups.
非常感謝讓我提問。我有三個問題。第一個,我想我聽到 Eric 提到擴編到 field manager 的層級,我想了解這對處方的「深度」或「廣度」哪一個影響更大?以及這兩個槓桿中,哪一個會影響達到財測指引上緣,或是影響指引區間擺動的因素?我還有兩個簡短追問。
Eric Foster - Chief Commercial Officer
Eric Foster - Chief Commercial Officer
Yeah, thanks for the question, Laura. So. I hate to say, but both actually. It's very hard getting the physician to write that first prescription. And so we want to make sure when they write the prescription that they have confidence that it will be filled. And that's what the field reimbursement manager does. They work with the physician's office to ensure as they navigate the payer dynamics that they're able to pull through and get that prescription filled.
好的,謝謝你的問題,Laura。嗯,我不太想這麼說,但其實兩者都有。要讓醫師開出第一張處方非常困難。所以我們希望確保當他們開出處方時,他們有信心這張處方能被配藥(filled)。這就是 field reimbursement manager 的工作。他們與醫師診所合作,確保在應對付款方(payer)動態時,能夠順利拉通(pull through)並讓處方完成配藥。
With regards to physicians as they continue to increase their depth of the prescribing, that same confidence is important, that not just the first one goes through but subsequent ones. So that team is really focused on helping prescriptions get pulled through, whether it's the first prescription or subsequent ones. I think you heard me say in my prepared remarks, we saw increase in riders as well as increase in depth of prescribing as well.
至於當醫師持續增加其處方深度時,同樣的信心也很重要——不只是第一張能過,後續的也要能過。所以這個團隊的重點就是協助處方拉通,不論是第一張或後續處方。我想你也聽到我在事先準備的發言中提到,我們看到開方醫師數(writers)增加,同時處方深度也增加。
So we are having impact across both of them, and that's why I kind of go to both of them to say that it's important to make it happen across both.
所以我們在兩者上都有影響,這也是為什麼我會說兩者都重要——必須同時在兩方面推動。
Michael Raab - President, Chief Executive Officer, Director
Michael Raab - President, Chief Executive Officer, Director
Laura, when Eric first started talking about hiring the skill set, one of the things that really opened my eyes is really very simple example. If I'm a salesperson, I worry that script is going to be filled. That's the way you're going to compensate me.
Laura,當 Eric 一開始談到招募這類技能組合時,有件事真的讓我大開眼界——用一個很簡單的例子:如果我是業務,我會擔心那張處方是否會被配藥。因為你會依此來給我薪酬。
So if I'm spending my time looking at Dr. Foster and whether or not that script is actually getting filled. I'm not calling on Dr. Raab because I'm worried about that. So bringing on the field access managers allows the ABDs to have confidence that they can drive the top of the funnel and that there will be those there to help pull through at the bottom of the funnel, resulting in compensation, ultimately an incentive comp.
所以如果我把時間花在盯著 Foster 醫師那張處方到底有沒有真的被配藥,我就沒有去拜訪 Raab 醫師,因為我在擔心這件事。因此,引進 field access managers 讓 ABDs 有信心可以推動漏斗上端(top of the funnel),同時也有人在漏斗下端協助拉通(pull through),最終帶來薪酬、也就是獎金(incentive comp)。
So it is -- I don't think I would ever imagine not having both in the launch of a drug going forward.
所以——我想未來在新藥上市時,我很難想像不把這兩者都配置進去。
Laura Chico - Analyst
Laura Chico - Analyst
Okay. And I guess two quick follow-ups and kind of related to that. I think in the prepared remarks, I heard that the exposure paid rate was also up. Just curious if you could quantify that. And then with respect to ACCEL, the site activation on the pre-identified sites has moved really rapidly. How are you monitoring, I guess, any conversation around quality checks that you can do to ensure you're getting sites to adhere to protocols and recruiting the right patients would be helpful. But also what are your assumptions around discontinuation rates?
好的。我想再追問兩個簡短問題,也和這個有點相關。我想在事先準備的發言中,我聽到 exposure paid rate 也上升了。想請問能否量化一下?另外,關於 ACCEL,預先選定的站點啟動(site activation)推進得非常快。你們如何監測——我想是——任何關於品質檢核(quality checks)的討論?例如確保站點遵循試驗方案(protocols)並招募到合適患者。這會很有幫助。另外,你們對停用率(discontinuation rates)的假設是什麼?
Michael Raab - President, Chief Executive Officer, Director
Michael Raab - President, Chief Executive Officer, Director
Now, once the site is up and running, we don't pay any attention to it. No, you're right. I mean, for the quality of the patients, it's really important, right? And as you get the enthusiasm of startup, there's training and reminding people of why you started at any clinical trial, you have screen failures that happen. And then the sites get better and better at identifying the patients. So that's just a natural progression of clinical development and recruitment.
現在,一旦站點啟動運作,我們就完全不管了。不是的,你說得對。我的意思是,患者品質非常重要,對吧?而在啟動初期的熱情之下,會有訓練,也會提醒大家為什麼要開始任何臨床試驗;同時也會發生篩選失敗(screen failures)。接著站點會越來越擅長辨識合適患者。所以這就是臨床開發與招募的自然進程。
So Rajani, a couple of weeks now onto the job is into this with both feet and both arms and we all feel very good about both the quality of the sites as well as those sites learn and get better at enrollment that we see those failure rates begin to taper, which is something you factor into your projections of how you enroll.
所以 Rajani 上任幾週後就全力投入,我們大家對站點品質感到非常放心;同時隨著站點學習並在入組(enrollment)上越做越好,我們也看到那些失敗率開始趨緩下降——這也是你在預估招募進度時會納入的因素。
So I think we all feel very good about what we've said and ultimately the quality of the patients are going to be there defined by our inclusion/exclusion criteria, so feel very good about that quality that Rajani's team is ultimately and our CRO is following through with.
所以我想我們都對我們所說的內容感到非常有信心;最終患者品質會由我們的納入/排除標準(inclusion/exclusion criteria)來界定,因此我們對這個品質非常放心,而 Rajani 的團隊以及我們的 CRO 最終也會確實落實執行。
And with regards to your first question, I think what's important is on a GAAP basis, of course, the year-over-year quarters look similar, it is so important what Sue reminded everyone of is that $3.8 million return reserve reversal that we did in Q1 should be excluded as you look at the base business that we've defined, which is a non-medicare business, which grew by 19%.
至於你的第一個問題,我想重點是:在 GAAP 基礎下,當然年對年季度看起來相近;但正如 Sue 提醒大家的,第一季我們做了 380 萬美元的退貨準備回轉(return reserve reversal),在你看我們所定義的基礎業務時應該排除——也就是非 Medicare 的業務——該業務成長了 19%。
And if you look at our sequential growth, even since we started in this effort to not participate into [DAPA] because we believe what we are now seeing is ultimately what was going to be true is proving out. And the growth that we're seeing in that non-medicare segment, with all the challenges that dialysis organizations are facing, further emphasizes the value of this program and the product for patients who need phosphorus management.
而如果你看我們的季對季成長,即使自從我們開始這項不參與 [DAPA] 的努力以來——因為我們相信我們現在看到的,最終會證明我們當時的判斷是正確的——我們在非 Medicare 區隔看到的成長,在透析機構面臨各種挑戰的情況下,更加凸顯這個計畫以及產品對需要磷管理(phosphorus management)的患者所帶來的價值。
So it's an opaque and difficult business that we've chosen to partake in in the way that we have, but the numbers are showing that actually we're helping the patients that we anticipated that we would.
因此,這是一門不透明且困難的業務,而我們選擇以目前的方式參與其中;但數據顯示,實際上我們正在幫助那些我們原先預期會幫助到的病患。
Laura Chico - Analyst
Laura Chico - Analyst
Thanks very much.
非常感謝。
Operator
Operator
Prakhar Agrawal,Cantor Fitzgerald.
Prakhar Agrawal,Cantor Fitzgerald。
Prakhar Agrawal - Analyst
Prakhar Agrawal - Analyst
Hi, thank you for taking my questions and congrats on the quarter as well. Maybe firstly on XPHOZAH, maybe I missed this, but I did not hear you reiterate the long-term guide of $750 million. I know the feed is a little bit more conservative, but I just wanted to check, if we are reiterating that.
嗨,謝謝你們回答我的問題,也恭喜本季表現。首先關於 XPHOZAH,也許我漏聽了,但我沒有聽到你們重申長期指引 7.5 億美元。我知道市場預期可能稍微保守一些,但我想確認一下,我們是否仍重申該目標。
And you talked about investing in high-value opportunities as well. So has there been a change in the level of investments for exposure this year and maybe in the future too?
另外你們也提到會投資於高價值機會。因此,今年以及未來,針對 XPHOZAH 的投資水準是否有所改變?
Secondly, maybe if you can talk about the growth to net for both products for 1Q and trends for the rest of the year. And last question, given the investments you're making both on the R&D side and SG&A, how should we think about the cash flow profitability.
第二,能否談談兩個產品在第一季的毛到淨(GTN)情況,以及今年其餘時間的趨勢。最後一個問題,考量你們在研發與銷售、一般及行政(SG&A)方面的投資,我們應該如何看待現金流獲利能力?
Susan Hohenleitner - Chief Financial Officer
Susan Hohenleitner - Chief Financial Officer
Thanks, Prakhar. That's a lot for me. So let's see if I can hit it all. So in terms of the high-value opportunities with XPHOZAH, yes, we ensure that XPHOZAH continues to be a contributor. So we don't necessarily tease out separate product P&Ls, but rest assured, we continue to ensure that all of the spending that's done, any investments we make behind those patients and that growth makes them a financial contributor. So that's good.
謝謝你,Prakhar。你問了很多,我來看看能不能都回答到。就 XPHOZAH 的高價值機會而言,是的,我們會確保 XPHOZAH 持續做出貢獻。我們不一定會拆分各產品的損益表,但請放心,我們會持續確保所有支出、以及我們在這些病患與成長背後所做的任何投資,都能讓它成為財務上的貢獻者。這點是好的。
In terms of the GTN, you probably saw in what we filed, we're a little over 36.4% of GTN, and that's a blend. We don't necessarily list that out. And what I'd say is first quarter is going to be really probably your highest quarter in terms of GTN, just given all the dynamics with co-pay, assistance, et cetera.
就 GTN 而言,你可能在我們的申報文件中看到,我們的 GTN 稍高於 36.4%,那是混合後的數字。我們不一定會把它逐項列出。我想說的是,第一季很可能會是全年 GTN 最高的一季,主要是因為自付額補助、援助計畫等各種動態因素。
And what we've always said before is it's about low 30s when you think about a blended total GTN rate for the year. But I would say that so you'll see that high in Q1 and then kind of taper off as we go into further quarters.
而我們過去一直說,若以全年混合後的總 GTN 率來看,大約在 30% 出頭。但我會說,你會在第一季看到較高,之後在接下來幾季會逐步回落。
Before I leave XPHOZAH, yes, we will reiterate the $750, and I am reiterating that. So within the guidance, we've given the $1 billion for IBSRELA and the $750 for XPHOZAH.
在我離開 XPHOZAH 這個話題前,是的,我們會重申 7.5 億美元,我現在就在重申。也就是在我們給出的指引中,IBSRELA 為 10 億美元,XPHOZAH 為 7.5 億美元。
In terms of R&D and SG&A, it was more around the expenses for the rest of the year? Yes. So I would say, and with cash flow, it is something that we're continuing to monitor. As you can see with the top-line guide, being $520,000 to $550,000 and our OpEx only at $520,000, there is a possibility we'll get to cash flow positivity. But certainly, we want to continue to see how the year unfolds and make sure that we're hitting on all cylinders. And then we will likely come back with an update if it's appropriate on cash.
至於研發與 SG&A,問題比較是關於今年剩餘時間的費用?是的。我會說,至於現金流,我們也持續在監控。如你所見,我們的營收指引為 520,000 到 550,000,而我們的營運費用(OpEx)僅為 520,000,因此有可能達到現金流轉正。但我們當然希望持續觀察今年的進展,確保各方面都運轉順利。若合適的話,我們之後也可能會就現金狀況提供更新。
Michael Raab - President, Chief Executive Officer, Director
Michael Raab - President, Chief Executive Officer, Director
And we appreciate the question of wanting the trajectory quarter-to-quarter, but we're not going to get into the practice of quarter guidance. I think the yearly guidance that Sue just went through is really important.
我們也理解你希望看到逐季的走勢,但我們不會養成提供季度指引的做法。我認為 Sue 剛剛說明的年度指引非常重要。
Operator
Operator
Matthew Caufield, HC Wainwright. P
Matthew Caufield,HC Wainwright。P
Matthew Caufield - Equity Analyst
Matthew Caufield - Equity Analyst
Hi, thank you, guys. With the investor focus on sales execution, is there further granularity that you could share on its relative growth between the new patient starts versus refill persistence trends? And then where things may stand presently for the total penetration among target prescribers there. Just thanks for any color there on execution overall.
嗨,謝謝各位。鑑於投資人關注銷售執行,你們是否能提供更細的資訊,例如新病患起始用藥(new patient starts)相對於續配持續性(refill persistence)趨勢的成長貢獻?另外,目前在目標開立處方醫師中的總滲透率大概到哪裡了?謝謝你們就整體執行面提供任何補充。
Michael Raab - President, Chief Executive Officer, Director
Michael Raab - President, Chief Executive Officer, Director
Yeah, I think that's getting into detail that we probably wouldn't get into specifics on. You can begin to look through your script data in terms of NRXs versus TRXs and tease that out to some extent with what you do. I recognize that it's going to be imperfect data.
是的,我想那會進入我們可能不會提供具體細節的層級。你可以透過處方數據,從新處方(NRXs)與總處方(TRXs)的角度去看,並在你自己的分析中某種程度上拆解。我也理解那會是不完美的數據。
But suffice it to say, with Eric's prepared remarks that we're seeing both with the other question that was asked, breadth and depth. So we're seeing great refills and we're seeing lots of new prescriptions coming through as well.
但簡單來說,正如 Eric 在事先準備的發言中提到的,以及剛才另一個問題所問到的,我們看到的是廣度與深度兩方面的提升。因此,我們看到很好的續配表現,也看到大量新處方持續進來。
Andrew Casson - Analyst
Andrew Casson - Analyst
Eric, anything to add?
Eric,有沒有要補充的?
Eric Foster - Chief Commercial Officer
Eric Foster - Chief Commercial Officer
No.
沒有。
Operator
Operator
Julian Harrison, BTIG.
Julian Harrison,BTIG。
Andrew Casson - Analyst
Andrew Casson - Analyst
Hi, this is Andrew Casson on for Julian. Congratulations on the results this quarter, and thanks for taking our question. On IBSRELA, which of the growth drivers would you say do you believe still has the most room to grow, writers, new prescriptions, refill, or pull through? Thank you.
嗨,我是代 Julian 提問的 Andrew Casson。恭喜本季成果,也謝謝你們回答問題。關於 IBSRELA,你們認為哪些成長驅動因素仍有最大成長空間:開立醫師數(writers)、新處方、續配,或拉動效應(pull through)?謝謝。
Michael Raab - President, Chief Executive Officer, Director
Michael Raab - President, Chief Executive Officer, Director
I think Eric will probably say yes to all of the above. I think what's interesting is for the 7 million prescriptions for IBSC-indicated products that I referenced in my opening remarks, it's a very small percentage of the market that one needs to penetrate in order to get to our guidance of peak. So there is massive opportunity out there.
我想 Eric 可能會說以上皆是。有趣的是,我在開場提到針對 IBS-C 適應症產品每年約 700 萬張處方;要達到我們所指引的峰值目標,只需要滲透市場中非常小的一部分。因此,外部仍有巨大的機會。
And I think. Eric, any granularity around the specifics would be great.
我想……Eric,如果能就具體面提供一些更細的說明會很棒。
Eric Foster - Chief Commercial Officer
Eric Foster - Chief Commercial Officer
Sure, yes. I'm very excited about all of them as you list them. So as we think about the IBSRELA opportunity, as Mike said, there are 7 million prescriptions written for IBS-C on an annual basis, and we continue to see that market grow. We feel very confident in the position that we have, a winning position sustainable over time that we've had for the past three years. And we continue to see an increase in riders, total riders, new riders, as well as depth of prescribing. And that's really important.
當然,可以。我對你列出的每一項都非常興奮。當我們思考 IBSRELA 的機會時,如 Mike 所說,IBS-C 每年約有 700 萬張處方,而且我們持續看到該市場成長。我們對自身的定位非常有信心:這是一個能長期維持的勝出位置,而我們在過去三年一直保持這樣的優勢。我們也持續看到開立醫師數增加,包括總開立醫師數、新增開立醫師數,以及處方深度的提升。這點非常重要。
So what that as physicians continue to have confidence in IBSRELA and look at it as a viable options for their patients that are in need. So of those patients, we know that 77% continue to have symptoms despite treatment with the secretagogue. So very healthy market, strong position for IBSRELA, continuing to go riders as well as depth of prescribing and feel really good about the opportunity we have moving forward.
也就是說,隨著醫師對 IBSRELA 的信心持續提升,並將其視為能滿足有需求病患的可行選項。對於這些病患,我們知道有 77% 即使接受促分泌劑(secretagogue)治療仍持續有症狀。因此市場非常健康,IBSRELA 的地位強勁,開立醫師數與處方深度持續成長,我們也對未來的機會感到非常樂觀。
When you think about the IBSRELA Pharmacy Network and being able to improve the fulfillment rate as well as the number of refills for patients, it really is -- really leads to success across the business in those important drivers of the business. And that's really what gives us that confidence to that $1 billion in 2029 and beyond.
當你想到 IBSRELA 的藥局網路(Pharmacy Network),以及我們能夠提升配藥履約率(fulfillment rate)與病患續配次數時,這確實——確實會帶動業務在這些重要驅動因素上的成功。也正是這些,讓我們對 2029 年及之後達到 10 億美元更有信心。
Andrew Casson - Analyst
Andrew Casson - Analyst
Thank you very much.
非常感謝。
Operator
Operator
There are no further questions at this time. This now concludes today's conference call. Thank you for joining. You may now disconnect.
目前沒有其他問題。今天的電話會議到此結束。感謝各位參與。您現在可以掛線。