Corcept Therapeutics Incorporated (CORT) 2026 Q2 法說會逐字稿

Thank you for standing by, and welcome to the Corcept Therapeutics second quarter 2026 earnings conference call. (Operator Instructions) As a reminder, today's program is being recorded.

感謝各位稍候，歡迎參加 Corcept Therapeutics 2026 年第二季財報電話會議。(接線員指示) 提醒各位，今天的會議將被錄音。

And now I'd like to introduce your host for today's program, Atabak Mokari, CFO. Please go ahead, sir.

現在我想介紹今天會議的主持人：財務長 Atabak Mokari。先生，請開始。

Hello, everyone. Good afternoon, and thank you for joining us. Today, we issued a press release announcing our financial results for the second quarter and providing a corporate update. A copy is available at corcept.com. Our complete financial results will be available when we file our Form 10-Q with the SEC.

各位好。下午好，感謝各位加入我們。今天我們發布新聞稿，公布第二季財務結果並提供公司最新進展。新聞稿可於 corcept.com 取得。我們在向美國證券交易委員會（SEC）提交 10-Q 表格後，將提供完整的財務結果。

Today's call is being recorded. A replay will be available at the Investors, Past Events tab of our website. Statements during this call, other than statements of historical fact, are forward-looking statements based on our plans and expectations that are subject to risks and uncertainties, which might cause actual results to be materially different from those such statements expressed or implied. The risks and uncertainties that may affect our forward-looking statements are described in our annual report on Form 10-K and our quarterly reports on Form 10-Q, which are available on the SEC's website. Please refer to those documents for more information.

今天的電話會議將被錄音。重播將可於我們網站「投資人」之「過往活動」分頁取得。本次電話會議中除歷史事實陳述外的其他陳述，均為前瞻性陳述，係基於我們的計畫與預期，並受風險與不確定性影響，可能導致實際結果與該等陳述明示或暗示者存在重大差異。可能影響我們前瞻性陳述的風險與不確定性，已載於我們的 10-K 年報及 10-Q 季報，相關文件可於 SEC 網站查閱。請參閱上述文件以取得更多資訊。

We disclaim any intention or duty to update forward-looking statements. Our revenue in the second quarter of 2026 was $256.1 million, a 32% increase over the prior-year period. Korlym and authorized generic product revenue was $208.6 million. Lifyorli product revenue was $47.6 million in its first quarter of availability. We expect growth to continue and have increased our 2026 revenue guidance to a range of $1.1 billion to $1.2 billion.

我們不承擔更新前瞻性陳述的任何意圖或義務。2026 年第二季營收為 2.561 億美元，較去年同期成長 32%。Korlym 及授權學名藥產品營收為 2.086 億美元。Lifyorli 產品營收為 4,760 萬美元，為其上市供應後的第一個季度。我們預期成長將持續，並已將 2026 年營收指引上調至 11 億至 12 億美元區間。

Net income was $43 million in the second quarter of 2026 compared to net income of $35 million in the prior-year period. Please note that our operating expenses in the second quarter were flat to the first quarter of 2026. Our cash and investments at June 30 were $545 million.

2026 年第二季淨利為 4,300 萬美元，去年同期淨利為 3,500 萬美元。請注意，我們第二季的營業費用與 2026 年第一季持平。截至 6 月 30 日，我們的現金及投資為 5.45 億美元。

I will now turn the call over to Sean Maduck, President of our Endocrinology division. Sean?

接下來我將把電話交給我們內分泌事業部總裁 Sean Maduck。Sean？

Thanks, Atabak. Our Cushing's syndrome business continues to experience strong demand. The second quarter saw a record number of new prescriptions and first-time prescribers. We have never had more patients receiving our medications or more active prescribers. Our growth is due to physicians increasing awareness that hypercortisolism is a serious disease that is more prevalent than previously understood.

謝謝你，Atabak。我們的庫欣氏症業務持續面臨強勁需求。第二季的新處方數與首次開立處方的醫師數皆創下紀錄。我們從未有過這麼多正在使用我們藥物的病患，也從未有過這麼多活躍的開立處方醫師。我們的成長來自於醫師日益認知到：高皮質醇症是一種嚴重疾病，其盛行率高於先前的理解。

Hypercortisolism is underdiagnosed because its signs and symptoms such as difficult-to-treat diabetes or resistant hypertension are the same as those of other more common conditions. Tens of millions of people have diabetes or hypertension or both, but those patients whose conditions are being driven by hypercortisolism have often been missed.

高皮質醇症常被漏診，因其徵象與症狀（例如難以控制的糖尿病或抗藥性高血壓）與其他更常見疾病相同。有數千萬人患有糖尿病或高血壓或兩者兼具，但其中病因由高皮質醇症驅動的患者，往往被忽略。

That is especially important because hypercortisolism-induced hyperglycemia or hypertension responds poorly, if at all, to conventional pharmacotherapy. A drug that reduces excess cortisol activity is required to treat these patients. As clinical practice adapts to this critical insight, screening for and treatment of Cushing's syndrome will continue to increase as will the number of patients receiving our medications.

這點尤其重要，因為由高皮質醇症引起的高血糖或高血壓，對傳統藥物治療反應不佳，甚至完全無反應。治療這些患者需要能降低過量皮質醇活性的藥物。隨著臨床實務逐步採納這項關鍵洞見，庫欣氏症的篩檢與治療將持續增加，使用我們藥物的患者人數也將隨之上升。

Our landmark CATALYST and MOMENTUM trials are driving increased physician awareness of hypercortisolism. CATALYST showed that 24% of patients with difficult-to-treat diabetes had hypercortisolism and that treatment with Korlym led to substantial reductions in hemoglobin A1c, excess body weight and waist circumference.

我們具里程碑意義的 CATALYST 與 MOMENTUM 試驗正在提升醫師對高皮質醇症的認知。CATALYST 顯示，24% 的難以治療糖尿病患者患有高皮質醇症，且以 Korlym 治療可顯著降低糖化血色素（HbA1c）、過多體重與腰圍。

MOMENTUM screened more than 1,000 patients with high blood pressure that was not controlled despite concurrent use of three or more anti-hypertension medications, a condition known as resistant hypertension, and found that 27% of these patients had hypercortisolism. In patients with both resistant diabetes and resistant hypertension, the prevalence of hypercortisolism was even higher, 39.7% in CATALYST and 32.6% in MOMENTUM. These paradigm-shifting findings will take time to be fully incorporated into medical practice, a process that is only just beginning.

MOMENTUM 篩檢了超過 1,000 名高血壓患者；這些患者即使同時使用三種或以上降壓藥仍無法控制血壓，此狀況稱為抗藥性高血壓；研究發現其中 27% 患有高皮質醇症。在同時具有抗藥性糖尿病與抗藥性高血壓的患者中，高皮質醇症的盛行率更高：CATALYST 為 39.7%，MOMENTUM 為 32.6%。這些將改變典範的發現，需要時間才能被完整納入醫療實務，而這個過程才剛開始。

CATALYST results were published in the field's leading journal, Diabetes Care, in 2025 and were referenced in the American Association of Clinical Endocrinology, or AACE, guidance documents for the management of diabetes in March of this year.

CATALYST 結果已於 2025 年發表在該領域的頂尖期刊《Diabetes Care》，並於今年 3 月被美國臨床內分泌學會（AACE）的糖尿病管理指引文件引用。

MOMENTUM's results are also recent. We first presented them at the Annual Conference of the American College of Cardiology or ACC in March, and again at the American Diabetes Association, or ADA, annual scientific sessions in June. The results will be published in a major medical journal later this year. That being said, the CATALYST and MOMENTUM results are becoming more widely known and doctors are acting upon them. Screening for and treatment of Cushing's syndrome is increasing and with it, the number of patients being treated with our medications.

MOMENTUM 的結果也相當新近。我們於 3 月在美國心臟學會（ACC）年會首次發表，並於 6 月在美國糖尿病學會（ADA）年度科學會議再次發表。研究結果將於今年稍晚發表於重要醫學期刊。即便如此，CATALYST 與 MOMENTUM 的結果正被更廣泛地認識，醫師也正在據此採取行動。庫欣氏症的篩檢與治療正在增加，使用我們藥物治療的患者人數亦隨之上升。

We expect this trend to continue, propelling our current Cushing's syndrome business to at least $2 billion in annual revenue by the end of this decade. Relacorilant's availability, which should occur shortly after the December 17 PDUFA date assigned to its resubmission, will accelerate this growth. With the addition of relacorilant, we expect that our Cushing's syndrome annual revenue will grow to between $3 billion and $5 billion in 2020 (sic - 2030).

我們預期此趨勢將持續，推動我們現有的庫欣氏症業務在本十年末達到至少每年 20 億美元的營收。Relacorilant 的上市供應（預期將在其重新送件所獲指定的 12 月 17 日 PDUFA 日期後不久發生）將加速此成長。隨著 relacorilant 的加入，我們預期庫欣氏症年度營收將在 2020 年（原文如此—應為 2030 年）成長至 30 億至 50 億美元之間。

I will now turn the call over to Roberto Vieira, President of our Oncology division. Roberto?

接下來我將把電話交給我們腫瘤事業部總裁 Roberto Vieira。Roberto？

Thanks, Sean. Lifyorli's launch is one of the strongest ever for an oncology medication. The FDA approved Lifyorli on March 25, nearly four months ahead of its PDUFA date. A few days after that, on April 1, we sold our first Lifyorli capsules. Revenue for the first quarter was $47.6 million.

謝謝你，Sean。Lifyorli 的上市表現是腫瘤藥物史上最強勁之一。FDA 於 3 月 25 日核准 Lifyorli，較其 PDUFA 日期提前近四個月。幾天後的 4 月 1 日，我們售出第一批 Lifyorli 膠囊。第一季營收為 4,760 萬美元。

Our success has been driven in large part by Lifyorli's compelling clinical characteristics. Patients with ovarian cancer have few good treatment options. This is especially true for those with platinum-resistant ovarian cancer. They and their physicians are excited to have a new treatment backed by strong efficacy data, a very manageable safety profile, convenient oral administration and no biomarker requirement. Accordingly, Lifyorli is on its way to becoming a new standard of care.

我們的成功在很大程度上來自 Lifyorli 具吸引力的臨床特性。卵巢癌患者可用的良好治療選項不多。對於鉑類抗藥性卵巢癌患者更是如此。患者及其醫師很高興能有一項新療法，具備強而有力的療效數據支持、相當可控的安全性概況、便利的口服給藥方式，且不需要生物標記物。因此，Lifyorli 正朝著成為新的標準治療邁進。

Payer coverage for Lifyorli has been excellent. The National Comprehensive Cancer Network, or NCCN guidelines listed Lifyorli as a preferred regimen just 15 days after approval, an unusually quick action that has supported broad insurance coverage and accelerated physician adoption. As of today, more than 70% of the combined Medicare, Medicaid and commercial lives have formal coverage policies for Lifyorli in place. More than 1,300 patients have now started treatment with Lifyorli, a number that continues to grow every day. Demand has come from gynecology, medical and hematology oncologists in academic and non-teaching hospitals as well as community oncology clinics across the country.

Lifyorli 的支付方（保險）給付覆蓋表現非常出色。美國國家綜合癌症網絡（NCCN）治療指引在核准後僅 15 天就將 Lifyorli 列為優先推薦方案；這是極不尋常的快速行動，支持了廣泛的保險覆蓋並加速醫師採用。截至今日，合計 Medicare、Medicaid 與商業保險的受保人中，已有超過 70% 具備針對 Lifyorli 的正式給付政策。目前已有超過 1,300 名患者開始接受 Lifyorli 治療，且該數字每天持續成長。需求來自全國各地教學與非教學醫院以及社區腫瘤診所的婦科腫瘤科、內科腫瘤科與血液腫瘤科醫師。

As of today, more than 1,000 doctors have prescribed Lifyorli to at least one patient and an increasing number of physicians have written prescriptions for multiple patients. While we are extremely pleased with Lifyorli's rapid uptake, we are just getting started. In the near term, we expect to reach more physicians at more oncology practices, large and small. We also expect physicians to prescribe Lifyorli more frequently as they gain experience with the drug. Those efforts alone should grow Lifyorli's annual revenue in the United States to more than $1 billion.

截至今日，已有超過1,000名醫師至少為一位病患開立 Lifyorli 處方，且越來越多醫師已為多位病患開立處方。我們對 Lifyorli 的快速採用感到非常振奮，但這才剛剛開始。短期內，我們預期能觸及更多醫師、更多腫瘤科診所，無論規模大小。我們也預期，隨著醫師對該藥物累積更多使用經驗，將更頻繁地開立 Lifyorli。僅憑這些努力，就應可使 Lifyorli 在美國的年營收成長至超過10億美元。

I will now turn the call over to Joe Belanoff, our Chief Executive Officer. Joe?

接下來我將把電話交給我們的執行長 Joe Belanoff。Joe？

Thank you, Roberto, and thank you, everyone, for joining us. Since our founding, Corcept has worked to discover (technical difficulty)

謝謝你，Roberto，也謝謝各位加入我們。自我們創立以來，Corcept 一直致力於發現(技術問題)

Ladies and gentlemen, please stand by, your program will resume momentarily. Once again, please stand by, your program will resume momentarily. Ladies and gentlemen, please stand by, your conference call will resume momentarily. Once again, please stand by, your conference call will resume momentarily.

各位女士先生，請稍候，節目將於片刻後恢復。再次提醒，請稍候，節目將於片刻後恢復。各位女士先生，請稍候，您的電話會議將於片刻後恢復。再次提醒，請稍候，您的電話會議將於片刻後恢復。

Okay. We're back. I apologize --

好的。我們回來了。我很抱歉--

You may --

您可以--

Yeah. I apologize to everyone. We had a drop in the telephone line, but I will start my section again. Thank you, Roberto, for your oncology update, and thank you, everyone, for joining us. Since our founding, Corcept has worked to discover and develop molecules that harness glucocorticoid receptor, GR, antagonists to treat serious diseases. We have made important progress. It is now established that hypercortisolism is much more prevalent than previously believed and that modulating cortisol's activity can help many patients.

是的。我向各位致歉。我們的電話線路中斷了，但我會重新開始我這一段。謝謝你，Roberto，提供腫瘤科的最新進展，也謝謝各位加入我們。自我們創立以來，Corcept 一直致力於發現並開發分子，運用糖皮質激素受體（GR）拮抗劑來治療嚴重疾病。我們已取得重要進展。目前已確立，高皮質醇症的盛行率遠高於先前所認為，而調節皮質醇活性可幫助許多病患。

Lifyorli's unprecedented uptake as a treatment for platinum-resistant ovarian cancer is eye-catching and is an important step to proving that GR antagonism can help treat many types of solid tumors, and our plans go well beyond Cushing's syndrome and oncology. Relacorilant's new drug application, NDA, in Cushing's syndrome is based on the positive outcome of our pivotal Phase III GRACE trial with confirmatory evidence from our double-blind, placebo-controlled Phase III GRADIENT trial, our long-term extension study and our earlier-stage development data.

Lifyorli 作為治療鉑抗性卵巢癌的前所未有採用速度引人注目，並且是證明 GR 拮抗作用可協助治療多種實體腫瘤的重要一步；而我們的規劃遠不止於庫欣氏症候群與腫瘤領域。Relacorilant 在庫欣氏症候群的新藥申請（NDA）係基於我們關鍵性第三期 GRACE 試驗的正面結果，並有雙盲、安慰劑對照的第三期 GRADIENT 試驗、長期延伸研究以及更早期開發資料所提供的確認性證據。

Collectively, these results show that patients treated with relacorilant experienced meaningful durable improvements in the signs and symptoms of Cushing's syndrome and without the serious adverse events associated with the currently approved medications, hypokalemia, endometrial hypertrophy, vaginal bleeding, adrenal insufficiency or QT prolongation. To say that we were disappointed when we received a complete response letter at the end of last year is an understatement. At our meeting with the FDA in April, the agency requested additional analyses of the data in our original NDA submission.

綜合而言，這些結果顯示，接受 relacorilant 治療的病患在庫欣氏症候群的徵象與症狀上獲得具臨床意義且持久的改善，且未出現目前已核准藥物所伴隨的嚴重不良事件，包括低血鉀、子宮內膜肥厚、陰道出血、腎上腺功能不全或 QT 延長。若說我們在去年年底收到完整回覆函（complete response letter）時感到失望，那還算輕描淡寫。在我們四月與 FDA 的會議中，該機構要求對我們原始 NDA 送件中的資料進行額外分析。

We completed those analyses, and based on their results, we resubmitted our NDA on June 17. The FDA accepted our resubmission and has assigned a PDUFA date of December 17, 2026. It is important to make relacorilant available as soon as possible. As Sean said, the CATALYST and MOMENTUM studies are changing medicine. As screening for hypercortisolism becomes the norm rather than the exception in patients with resistant diabetes and hypertension, many patients whose health has been damaged by previously undiagnosed hypercortisolism will be able to receive more effective targeted care.

我們已完成這些分析，並根據其結果於 6 月 17 日重新提交 NDA。FDA 已受理我們的重新提交，並訂定 PDUFA 日期為 2026 年 12 月 17 日。讓 relacorilant 盡快可用非常重要。如 Sean 所說，CATALYST 與 MOMENTUM 研究正在改變醫療。隨著對難治型糖尿病與高血壓病患進行高皮質醇症篩檢成為常態而非例外，許多健康已因先前未診斷的高皮質醇症而受損的病患，將能獲得更有效的標靶式照護。

Better treatments are greatly needed. The approval of Lifyorli was enormously gratifying. It is wonderful to be able to offer patients with platinum-resistant ovarian cancer, one of the most challenging forms of cancer, a safe and effective treatment option. We presented complete results from Lifyorli's pivotal trial, ROSELLA, in April at the Society of Gynecologic Oncology, SGO's Annual Meeting with their simultaneous publication in the Lancet. In ROSELLA, Lifyorli met both primary endpoints, significantly delaying disease progression and even more important, significantly extending overall survival.

更好的治療極為迫切。Lifyorli 的核准令人非常欣慰。能為鉑抗性卵巢癌病患——這是最具挑戰性的癌症之一——提供安全且有效的治療選項，令人振奮。我們於四月在婦科腫瘤學會（SGO）年會上發表 Lifyorli 關鍵性試驗 ROSELLA 的完整結果，並同步刊登於《刺胳針》（The Lancet）。在 ROSELLA 中，Lifyorli 達成兩項主要終點，顯著延緩疾病進展，更重要的是，顯著延長整體存活期。

Patients treated with Lifyorli and nab-paclitaxel chemotherapy experienced a 35% reduction in their risk of death, a hazard ratio of 0.65 compared to patients treated with nab-paclitaxel alone. The p-value was 0.0004. Notably, these survival benefits were achieved in all patients with platinum-resistant ovarian cancer, not just those selected based on a specific biomarker. Lifyorli's approval is just the first step toward advancing GR antagonism's full potential to treat solid tumors. Many tumors exploit GR signaling to drive treatment resistance.

接受 Lifyorli 合併 nab-紫杉醇（nab-paclitaxel）化療的病患，其死亡風險降低 35%，相較於僅接受 nab-紫杉醇者之風險比（hazard ratio）為 0.65。p 值為 0.0004。值得注意的是，這些存活效益在所有鉑抗性卵巢癌病患中皆可達成，而非僅限於依特定生物標記篩選出的病患。Lifyorli 的核准只是推進 GR 拮抗作用在治療實體腫瘤方面完整潛力的第一步。許多腫瘤會利用 GR 訊號傳導來驅動治療抗性。

Beyond platinum-resistant ovarian cancer, GR antagonism has the potential to treat any solid tumor expressing the GR in combination with any anticancer agent. Our oncology development program aims to provide the evidence needed to realize the potential. We are evaluating relacorilant combined with chemotherapy in a variety of solid tumors. One of the arms of our BELLA trial is studying the effect of relacorilant plus nab-paclitaxel and bevacizumab in women with platinum-resistant ovarian cancer. This arm will produce results this year.

除鉑抗性卵巢癌之外，GR 拮抗作用有潛力在任何表現 GR 的實體腫瘤中，與任何抗癌藥物併用以進行治療。我們的腫瘤開發計畫旨在提供實現此潛力所需的證據。我們正在評估 relacorilant 與化療合併用於多種實體腫瘤。我們 BELLA 試驗的其中一個組別正在研究 relacorilant 合併 nab-紫杉醇與 bevacizumab，用於鉑抗性卵巢癌女性的效果。此組別將於今年產出結果。

Our BELLA trial has two other arms, one which is studying the treatment of patients with platinum-sensitive ovarian cancer, an earlier stage of the disease, and one which is studying endometrial cancer. Our STELLA trial in cervical cancer and our TRIDENT trial as a first-line treatment for pancreatic cancer are also underway. These trials will all produce results by the end of next year. We expect data from these studies to be NCCN-guideline enabling and to inform our future development decisions. Successful results would immediately increase the number of patients that relacorilant may help by fivefold.

我們的 BELLA 試驗另有兩個組別：一個研究鉑敏感性卵巢癌（疾病較早期）的治療，另一個研究子宮內膜癌。我們在子宮頸癌的 STELLA 試驗，以及作為胰臟癌第一線治療的 TRIDENT 試驗也正在進行中。這些試驗都將在明年年底前產出結果。我們預期這些研究的數據將可支持納入 NCCN 指引，並為我們未來的開發決策提供資訊。若結果成功，relacorilant 可能受益的病患人數將可立即增加五倍。

Also very important, GR antagonism may augment the effects of immunotherapy. Cortisol suppresses the immune system, blunting the effectiveness of therapies that stimulated an immune response. A treatment regimen combining an immunotherapy agent with a GR antagonist may stimulate a stronger, more effective immune response. We have initiated SYNERGY, a Phase Ib study of our proprietary selective GR antagonist, nenocorilant, in combination with nivolumab, a PD-1 directed immunotherapy across a broad range of solid tumors. We expect results from SYNERGY by the end of next year.

同樣非常重要的是，GR 拮抗作用可能增強免疫治療的效果。皮質醇會抑制免疫系統，削弱那些藉由刺激免疫反應而發揮作用之療法的有效性。將免疫治療藥物與 GR 拮抗劑結合的治療方案，可能引發更強且更有效的免疫反應。我們已啟動 SYNERGY，這是一項 Ib 期研究，評估我們自有的選擇性 GR 拮抗劑 nenocorilant 與 nivolumab（一種以 PD-1 為標的的免疫治療）合併使用，涵蓋廣泛的實體腫瘤。我們預期在明年年底前取得 SYNERGY 的結果。

Finally, cortisol activity at the GR stimulates the growth of prostate cancer tumors, helping them escape the effects of androgen deprivation therapy. Our collaborators at the University of Chicago are enrolling a randomized placebo-controlled Phase II trial of relacorilant plus the androgen receptor blocker, enzalutamide, in patients with early-stage prostate cancer to see if adding a GR antagonist can block cortisol-mediated tumor escape routes. Cortisol activities involved in the development and progression of metabolic dysfunction-associated steatohepatitis or MASH. This serious liver disorder afflicts millions of patients worldwide and is a significant and rapidly growing cause of liver and cardiometabolic morbidity and mortality. Our proprietary selective cortisol modulator, miricorilant, is very potent in the liver.

最後，皮質醇在 GR 上的活性會刺激前列腺癌腫瘤生長，協助其逃脫雄激素剝奪治療的效果。我們在芝加哥大學的合作夥伴正在招募一項隨機、安慰劑對照的第二期試驗，於早期前列腺癌病患中評估 relacorilant 合併雄激素受體阻斷劑 enzalutamide，以觀察加入 GR 拮抗劑是否能阻斷皮質醇介導的腫瘤逃脫途徑。皮質醇活性也參與代謝功能障礙相關脂肪性肝炎（MASH）的發生與進展。此嚴重肝臟疾病影響全球數以百萬計病患，且是肝臟與心臟代謝相關罹病率與死亡率的重要且快速成長的原因。我們自有的選擇性皮質醇調節劑 miricorilant 在肝臟中效力非常強。

In our Phase Ib study, it rapidly reduced liver fat and improved other elements of important markers of liver health, including fibrosis. Miricorilant was well tolerated without the gastrointestinal side effects commonly seen in patients being treated for NASH. Our 175-patient double-blind, placebo-controlled Phase IIb MONARCH study has completed enrollment and will produce data later this year. Positive results would support advancement to Phase III. Patients with ALS frequently have elevated cortisol levels, which is why we believe cortisol modulation may help them.

在我們的 Ib 期研究中，它迅速降低了肝臟脂肪，並改善了其他重要的肝臟健康指標要素，包括纖維化。Miricorilant 的耐受性良好，未出現在接受 NASH 治療的患者中常見的腸胃道副作用。我們的 175 名患者、雙盲、安慰劑對照的 IIb 期 MONARCH 研究已完成收案，並將於今年稍晚產出數據。若結果為正向，將支持推進至 III 期。ALS 患者常有皮質醇濃度升高，這也是我們相信調節皮質醇可能有助於他們的原因。

Results from DAZALS, the Phase II trial of our proprietary selective cortisol modulator, dazucorilant, have been very encouraging. Patients who received 300 milligrams of dazucorilant exhibited an 84% reduction in risk of death at the one year mark compared to patients who received placebo. The p-value for this finding was 0.0009. This survival benefit persisted into the study's second year with an 87% reduction in risk of death with a p-value of less than 0.0001. There is a common misperception that death from ALS is always coterminous with severe functional decline.

我們專有的選擇性皮質醇調節劑 dazucorilant 之 II 期 DAZALS 試驗結果非常令人鼓舞。與接受安慰劑的患者相比，接受 300 毫克 dazucorilant 的患者在一年時點的死亡風險降低了 84%。此發現的 p 值為 0.0009。此存活獲益延續至研究第二年，死亡風險降低 87%，p 值小於 0.0001。普遍存在一種誤解，認為 ALS 的死亡總是與嚴重的功能衰退同時發生。

It isn't. Many patients die from complications such as pneumonia or cardiovascular events arising well before they have lost significant function and quality of life. Cortisol modulation could prevent such complications or help patients to survive them, it would provide a significant benefit. We are currently conducting a study to see if dose titration can improve dazucorilant's gastrointestinal tolerability. Non-serious GI distress caused most of the discontinuations in DAZALS.

其實並非如此。許多患者在尚未喪失顯著功能與生活品質之前，就因肺炎或心血管事件等併發症而死亡。若皮質醇調節能預防此類併發症或幫助患者挺過併發症，將帶來顯著效益。我們目前正在進行一項研究，以評估劑量滴定是否能改善 dazucorilant 的腸胃道耐受性。在 DAZALS 中，多數停藥是由非嚴重的腸胃道不適所致。

The findings from this study will inform the design of the pivotal trial that we plan to start early next year. To sum up, our Cushing's syndrome business is growing and is poised for accelerated growth driven by increasing awareness of hypercortisolism's true prevalence and the increasing evidence of the importance of treating it. Our landmark CATALYST and MOMENTUM studies are leading to much wider screening for and treatment of Cushing's syndrome. Approval of relacorilant would lead to even faster growth. The launch of Lifyorli in platinum-resistant ovarian cancer is off to a very strong start.

本研究的發現將為我們計畫於明年初啟動的關鍵性試驗設計提供資訊。總結而言，我們的庫欣氏症候群業務正在成長，並有望在對高皮質醇症真實盛行率的認知提升，以及治療重要性證據日益增加的推動下加速成長。我們具里程碑意義的 CATALYST 與 MOMENTUM 研究正促使庫欣氏症候群的篩檢與治療更為廣泛。若 relacorilant 獲得核准，將帶來更快速的成長。Lifyorli 於鉑抗性卵巢癌的上市開局非常強勁。

We believe that GR antagonism has a broad utility in oncology. We look forward to helping many more patients with cancer in the near future. Our BELLA, STELLA and TRIDENT studies will produce results by the end of next year and have the potential to increase the number of patients Lifyorli could benefit by a factor of 5. We are also evaluating the treatment of other solid tumors and other treatment combinations to fully realize our potential in oncology. Following up on our positive Phase II DAZALS findings, we are conducting a dose titration study to inform the design of our planned Phase III trial in patients with ALS.

我們相信 GR 拮抗在腫瘤學領域具有廣泛用途。我們期待在不久的將來幫助更多癌症患者。我們的 BELLA、STELLA 與 TRIDENT 研究將於明年年底前產出結果，並有潛力將可受益於 Lifyorli 的患者人數提高 5 倍。我們也在評估其他實體腫瘤的治療以及其他治療組合，以充分實現我們在腫瘤學的潛力。在 DAZALS II 期正向結果的基礎上，我們正在進行一項劑量滴定研究，以為我們規劃中的 ALS 患者 III 期試驗設計提供依據。

By year-end, we will have results from our Phase II MONARCH trial in patients with MASH. If those results are sufficiently positive, we will proceed to Phase III. The potential of cortisol modulation is immense. Developing that potential into safe and effective medications is important work. We thank the patients who participate in our trials, our employees, our clinical investigators and our academic collaborators who make it possible.

在年底前，我們將取得 MASH 患者的 II 期 MONARCH 試驗結果。若結果足夠正向，我們將推進至 III 期。皮質醇調節的潛力極為龐大。將此潛力發展為安全且有效的藥物，是一項重要的工作。我們感謝參與試驗的患者、我們的員工、臨床研究者以及學術合作夥伴，讓這一切成為可能。

Operator, let's proceed to questions.

接線員，讓我們開始提問。

(Operator Instructions)

(接線員指示)

David Amsellem, Piper Sandler.

David Amsellem，Piper Sandler。

So just a few for me. First, on the patient-level metrics on Lifyorli. Can you talk to the number of patients on treatment currently or at the end of 2Q? And when you talk about accelerating demand, I'd just want to get a sense of what exactly that means. Does that mean you're adding -- the pace of patient adds continue to increase through June and into July?

我這邊只有幾個問題。首先，關於 Lifyorli 的病患層級指標。你們能談談目前或在第二季末（2Q）時正在接受治療的患者人數嗎？另外，當你們提到需求正在加速時，我想了解那具體代表什麼。這是否表示你們新增患者的速度在 6 月並延續到 7 月仍持續提升？

That kind of color would be helpful. And then secondly, on the upward revision to the guidance, is it fair to say that most of that is related to the launch of Lifyorli? And if so, can you talk to the dynamics you're seeing surrounding Korlym? Are there any additional bottlenecks or lingering bottlenecks, I should say, regarding the specialty pharmacy and what kind of assumptions are now embedded in the -- in Korlym with this upward revision to your guide?

這類補充說明會很有幫助。第二，關於上修財測指引，是否可以說其中大部分與 Lifyorli 的上市有關？若是如此，能否談談你們看到的 Korlym 相關動態？關於專科藥局方面，是否仍有任何額外的瓶頸或我應該說仍在持續的瓶頸？以及在這次上修指引下，對 Korlym 的假設目前包含了哪些內容？

Okay. Thank you, David. And several questions. I'll try to sort them out. On first question, I think we'll go to Roberto, our President of Oncology.

好的。謝謝你，David。你問了好幾個問題。我會試著把它們整理一下。第一個問題，我想請我們的腫瘤事業總裁 Roberto 來回答。

So thank you, Joe. Thank you, David. So David, we spoke about the 1,300 patients that we have initiated on therapy since we have launched. As you can see from what we discussed in the previous quarter as well, we have really accelerated the adoption of patients there. And we are very happy.

謝謝你，Joe。謝謝你，David。David，我們談到自上市以來，我們已讓 1,300 名患者開始接受治療。如同我們在上一季也討論過的，你可以看到我們確實大幅加速了患者的採用。我們非常高興。

We see a very broad range of patients. We see patients very early lines of therapy, but also patients across the entire spectrum, late lines as well. And we have maintained actually a very strong pace of adding patients every week. We are on our way to become market leaders as well as to realize the potential of $1 billion just for platinum-resistant ovarian cancer in itself. So I think that you can derive from there where we are headed.

我們看到的患者範圍非常廣。我們看到非常早期治療線的患者，也看到涵蓋整個光譜、包括後線治療的患者。而且我們實際上維持了每週新增患者的非常強勁速度。我們正朝著成為市場領導者邁進，也將實現僅就鉑抗性卵巢癌本身就有 10 億美元的潛力。所以我想你可以由此推知我們的方向。

We are very happy with market access as we discussed. So overall, the story holds together as significant growth is ahead of us. Now talking about this rate of acceleration of demand. We have, of course, as I said, very strong uptake so far, and we are actually working very hard to educate a much broader group of physicians that expands across new clinics. We think we have meaningful opportunity ahead.

如同我們所討論的，我們對市場准入非常滿意。因此整體而言，這個故事是連貫的，顯著的成長就在前方。接著談到需求加速的速度。當然，如我所說，到目前為止我們的採用非常強勁，而我們也正非常努力地教育更廣泛的醫師族群，並擴展到新的診所。我們認為前方有相當可觀的機會。

So our goal is to really go early and go broad. And when I say go early, we think that Lifyorli is a drug that belongs early in the intervention. We think that the overall survival benefit, especially the fact that the drug has the opportunity to impact the disease, has a disease modification effect. You look at the overall survival curve, you see that those curves separate over time. So there's an increasingly positive benefit to patients.

因此我們的目標是盡可能在早期、並且廣泛地推進。當我說「早期」，我們認為 Lifyorli 是一款應該在早期介入使用的藥物。我們認為整體存活獲益，尤其是該藥物有機會影響疾病本身、具有疾病修飾效果這一點，非常重要。你看整體存活曲線，會看到曲線隨時間拉開差距。因此對患者的正向效益會愈來愈明顯。

And all those things together points to this drug really belonging into early lines of platinum-resistant ovarian cancer. So when you put all this together, the profile of the drug, the all-comer opportunity, you should be looking to continuous growth for the brand for the quarters to come.

而這些因素加總起來，顯示這款藥物確實應該用於鉑抗性卵巢癌的早期治療線。因此，當你把這一切放在一起——藥物的特性、適用於所有患者族群的機會——你應該預期該品牌在接下來的各季將持續成長。

Very good. Thank you, Roberto. And Sean, why don't you take the next question about where things stand with the pharmacy?

非常好。謝謝你，Roberto。Sean，接下來關於藥局端目前的情況，為何不由你來回答？

Yeah. No, happy to take that. So in terms of just how the quarter ended up, I want to just set the stage. I mean, we had record enrollments. We had a record number of new prescribers, a record number of patients on medicine, which, of course, led to the highest tablets we've seen.

好的。很樂意回答。就本季最終結果而言，我先鋪陳一下背景。我們的收案數創下紀錄。我們的新開立處方醫師數創下紀錄、用藥患者數創下紀錄，當然也帶動了我們所見到的最高錠數。

The market is growing. And of course, that was evidenced in our business in the second quarter, but we expect that to continue to grow and of course, to continue to benefit our business. Now in terms of the pharmacy specifically, I mean, we saw a continuous improvement every single day, and we expect that continued improvement to move forward. As I just mentioned, the market is growing. Our business is growing, and we expect them to continue to improve and continue to keep up.

市場正在成長。當然，這在我們第二季的業務中已得到印證，但我們預期這種成長將持續，並且當然也將持續為我們的業務帶來助益。就藥局端而言，我的意思是，我們每天都看到持續改善，我們也預期這種持續改善將延續到未來。如我剛才提到的，市場正在成長。我們的業務也在成長，我們預期它們將持續改善並持續跟上步伐。

And Atabak, perhaps you can respond to the guidance question.

Atabak，也許你可以回應一下關於財測指引的問題。

Sure. Yeah. So our new guidance range reflects strength across both of our businesses, across both Endocrinology and Oncology. And so that's -- both of those are reflected in the updated guidance range.

當然。是的。因此，我們新的指引區間反映了我們兩大業務的強勁表現，涵蓋內分泌與腫瘤兩個領域。因此，更新後的指引區間已反映這兩者的表現。

Swayampakula Ramakanth, H.C. Wainwright.

Swayampakula Ramakanth，H.C. Wainwright。

I have just a couple of questions. One on Lifyorli and one on Korlym. On -- Lifyorli did approximately $48 million in the first quarter with more than 1,300 patients started, as you stated. How much of that reflects dispensed demand versus initial channel build? And how many unique prescribers do you have at this point beyond the 200 that you cited in April? And any commentary on duration of therapy would be helpful as well. And then on Korlym, we are back to seeing 27% sequential growth. How much of this is clearing up of the backlog from the pharmacy transition versus capacity growth that you currently have gained with a new pharmacy onboard?

我只有幾個問題。一個關於 Lifyorli，另一個關於 Korlym。關於——你們表示 Lifyorli 第一季約 4,800 萬美元，且啟動治療的病患超過 1,300 位。其中有多少反映的是實際出貨/配藥需求（dispensed demand），而非初期通路鋪貨（initial channel build）？另外，截至目前你們有多少位不重複的開立處方醫師（unique prescribers），是否已超過你們在四月提到的 200 位？也希望能就治療持續時間（duration of therapy）提供一些評論。再來談 Korlym，我們又看到 27% 的季對季成長。其中有多少是藥局轉換所造成的積壓訂單清理（backlog clearing），又有多少是你們目前因新藥局加入而獲得的產能成長（capacity growth）？

Okay. Thank you, RK. I think we got both of those questions. Roberto, would you like to answer the first question on oncology growth?

好的。謝謝你，RK。我想我們收到這兩個問題了。Roberto，你願意先回答第一個關於腫瘤業務成長的問題嗎？

Yeah. So RK, as you said, 1,300 patients initiated therapy and 1,000 unique prescribers since we have launched. So that is, I think, the answer to your question. You asked about the duration of therapy. It's kind of early for us to assess the duration of therapy. As you can imagine, most of our patients, we have followed them through for a couple of months or weeks. And we think that the ROSELLA data is a very good benchmark for us. So think about our PFS there. That's what we think that we will have that -- reflected in the patient population.

好的。RK，如你所說，自我們上市以來，已有 1,300 位病患開始治療，且有 1,000 位不重複的處方醫師。所以我想這就是你問題的答案。你問到治療持續時間。對我們來說，現在評估治療持續時間還有點早。如你所想像，多數病患我們目前僅追蹤了幾個月或幾週。我們認為 ROSELLA 的數據對我們而言是一個非常好的基準。所以可以參考我們在那裡的 PFS。我們認為在病患族群中也會反映出相同的情況。

Thank you, Roberto. And Sean --

謝謝你，Roberto。那 Sean--

He had a question on inventory --

他有一個關於庫存的問題--

Yeah. Okay. I'm sorry. Yes. The question was related to inventory. That's for you, Atabak.

是的。好的。不好意思。是。這個問題與庫存有關。Atabak，這題給你。

I'll take that one. So your question on that, RK, the simple answer is no, there's not much inventory contribution in the quarter results. And so what do I mean by that? So the background is that we sell through both specialty pharmacies and specialty distributors through -- revenues through the specialty pharmacy are direct to patient. So there is no inventory at the channel level. It's all direct to patient and realized when the patient receives the medicine. So through the specialty -- and in our -- and just to be clear, in our Cushing's syndrome business, almost 100% of our business goes through the specialty pharmacy.

我來回答這題。RK，關於你的問題，簡單的答案是：沒有，本季業績結果中庫存貢獻不大。那我這樣說是什麼意思？背景是，我們透過專科藥局與專科經銷商銷售——透過專科藥局的收入是直接面向病患。因此通路端不會有庫存。全部都是直接到病患手上，並在病患收到藥品時認列。因此在專科——而且為了說清楚，在我們庫欣氏症候群（Cushing's syndrome）業務中，幾乎 100% 都是透過專科藥局進行。

And on the oncology side, about 30% goes through the specialty pharmacy and the rest goes through specialty distributors, which do hold inventory to then ultimately provide to hospital pharmacies and so forth. Within that, I mean, ultimately, this is -- given the cost of the medication, the distributors want to hold minimal inventory. So you're talking about -- roughly about a week of demand that they keep on hand. So like I started at the beginning, very little of inventory dynamics in the quarter results.

而在腫瘤業務方面，大約 30% 透過專科藥局，其餘則透過專科經銷商；經銷商會持有庫存，最終提供給醫院藥局等。在這之中，考量到藥品成本，經銷商希望持有的庫存量越少越好。所以你談到的——大致上他們手上會維持約一週的需求量。因此如我一開始所說，本季結果中庫存動態的影響非常小。

Thank you. Okay. And Sean, you have a couple of questions here.

謝謝你。好的。Sean，你這邊還有幾個問題。

Yeah. So thanks, RK. So your question, I think, was the $44 million growth we saw from Q2 over Q1 driven by sort of catch-up associated with the pharmacy transition. And the answer to that is no. The transition is behind us. The number was driven by continued servicing of our existing patient base. And as I shared earlier, a record number of new enrollments coming in. So the servicing of new patients coming in. We've had a record number of patients every single month, and we expect that to continue to grow.

是的。所以謝謝你，RK。我想你的問題是，我們看到第二季相較第一季增加的 4,400 萬美元，是否是由於與藥局轉換相關的某種補進（catch-up）所驅動。答案是否定的。轉換已經在我們身後了。這個數字是由於我們持續服務既有病患基礎所帶動。而且如我先前分享的，新加入的註冊人數創下紀錄。因此也包括對新進病患的服務。我們每個月的病患數都創下新高，我們預期這將持續成長。

Thank you, Sean. Thank you. Well, thank you, everyone. It was a very exciting quarter for us. It's really wonderful to be able to help this new group of patients. We really hope to enlarge that as we go forward and really have great expectations that we will. So we'll talk to you next quarter. Thank you very much, and enjoy the rest of your summer. Bye-bye.

謝謝你，Sean。謝謝。那麼，謝謝各位。這對我們而言是非常令人振奮的一季。能夠幫助這一群新的病患真的很棒。我們非常希望在未來能擴大這個規模，也確實對此抱持很高的期待，我們相信能做到。那我們下季再聊。非常感謝，也祝各位夏日愉快。再見。

Thank you, ladies and gentlemen, for your participation in today's conference. This does conclude the program. You may now disconnect. Good day.

感謝各位女士、先生參與今天的會議。本次議程到此結束。您現在可以掛線。祝您有美好的一天。