Corcept Therapeutics Inc (CORT) 2025 Q1 法說會逐字稿

Thank you for standing by and welcome to Corcept Therapeutics first quarter 2025 earnings conference call.(Operator Instructions). I would now like to hand the call over to Atabak Mokari, CFO. Please go ahead.

感謝您的支持，歡迎參加 Corcept Therapeutics 2025 年第一季財報電話會議。 （操作員指示）。現在我想把電話交給財務長 Atabak Mokari。請繼續。

Hello everyone, good afternoon and thank you for joining us. Today we issued a press release announcing our financial results for the first quarter and providing a corporate update. The copy is available at corcept.com. Our complete financial results will be available when we file our [Form 10K] with the SEC. Today's call is being recorded. A replay will be available at the Investors past events tab on our website. Statements during this call other than statements of historical fact or 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 than those such statements express or imply. The risks and uncertainties that may affect our forward-looking statements are described in our annual report on Form 10K and our quarterly reports on Form 10, all of which are available at the SEC's website. Please refer to those documents for additional information. We disclaim any intention or duty to update forward-looking statements.

大家好，下午好，感謝大家的參與。今天我們發布了一份新聞稿，宣布了第一季的財務表現並提供了公司最新動態。副本可在 corcept.com 上取得。當我們向美國證券交易委員會提交 [10K 表格] 時，完整的財務結果將會公佈。今天的通話正在錄音。我們網站的「投資者過往事件」標籤頁中將提供重播。本次電話會議中的陳述除歷史事實陳述或基於我們的計劃和預期的前瞻性陳述外，還受到風險和不確定性的影響，這可能導致實際結果與此類陳述明示或暗示的結果存在重大差異。可能影響我們前瞻性陳述的風險和不確定性在我們的 10K 表年度報告和 10 表季度報告中均有描述，所有這些報告均可在美國證券交易委員會的網站上查閱。請參閱這些文件以獲取更多資訊。我們不承擔更新前瞻性陳述的任何意圖或義務。

Our revenue in the first quarter of 2025 was $157.2 million compared to $146.8 million in the first quarter of last year. We are reiterating our 2025 revenue guidance of $900 million to $950 million.

我們 2025 年第一季的營收為 1.572 億美元，而去年第一季的營收為 1.468 億美元。我們重申 2025 年 9 億至 9.5 億美元的營收預期。

Net income was $20.5 million in the first quarter of 2025 compared to $27.8 million in the first quarter of last year.

2025 年第一季淨收入為 2,050 萬美元，而去年第一季淨收入為 2,780 萬美元。

Our cash and investments at March 31 were $570.8 million. We acquired $43 million of our common stock in the first quarter of 2025 pursuant to our stock repurchase program, the net exercise of stock options by Corcept employees, and the net vesting of restricted stock.

截至 3 月 31 日，我們的現金和投資為 5.708 億美元。根據我們的股票回購計畫、Corcept 員工的股票選擇權淨行使以及限制性股票的淨歸屬，我們在 2025 年第一季收購了價值 4,300 萬美元的普通股。

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

現在我將把電話轉給我們內分泌科總裁 Sean Maduck。肖恩。

Thank you Atabak.

謝謝你，阿塔巴克。

We are on the cusp of a new diagnosis and treatment paradigm for patients with hypercortisolism. For many years, most physicians reserved both screening and treatment for the most physically obvious cases of hypercortisolism.

我們正處於皮質醇增多症患者新的診斷和治療模式的前沿。多年來，大多數醫生只對身體最明顯的皮質醇增多症病例進行篩檢和治療。

Over the last 15 years, published data has supported the identification and the treatment across a broader spectrum of disease. Screening for hypercortisolism has increased and it is driving rapid patient growth in our business. I'm certain that this is that this increase in screening is just beginning.

在過去的 15 年裡，已發表的數據支持了更廣泛疾病的識別和治療。皮質醇增多症的篩檢有所增加，這推動了我們業務中患者的快速成長。我確信篩檢的增加才剛開始。

I've never been more confident in both our current and future growth prospects, and most important, our potential to help many patients for years to come.

我對我們當前和未來的成長前景從未如此有信心，最重要的是，我們在未來幾年幫助眾多患者的潛力。

We now know that patients with hypercortisolisms exist in every medical practice. More and more physicians are starting to recognize that too.

我們現在知道，在每一種醫療實踐中都存在著患有皮質醇增多症的患者。越來越多的醫生也開始意識到這一點。

To put this in perspective, our new prescriber base has grown at a record rate for five straight quarters, and the number of prescriptions in the first quarter of this year was almost double what we saw in the same period last year.

從這個角度來看，我們的新處方數量已連續五個季度以創紀錄的速度增長，今年第一季的處方數量幾乎是去年同期的兩倍。

Both our prescriber base and our patient base are growing rapidly, and we expect growth to accelerate.

我們的處方醫生群體和患者群體都在快速成長，我們預計成長將會加速。

In 2023 and 2024, we amplified our efforts to educate physicians about hypercortisolism and [quorum]. We also increased the size of our sales force, and we will continue to grow that team to reach and serve all our potential customers. We currently have 125 clinical specialists, up from 60 at the beginning of 2024, and our plan is to have 175 in place before year end in preparation for Relacorilant's launch.

2023 年和 2024 年，我們加大了對醫生進行皮質醇增多症相關知識教育的力度，[法定人數]。我們也擴大了銷售團隊的規模，並將繼續擴大該團隊以接觸和服務所有潛在客戶。我們目前擁有 125 名臨床專家，比 2024 年初的 60 名有所增加，我們計劃在年底前擁有 175 名臨床專家，為 Relacorilant 的推出做準備。

In 2024, we also introduced our first direct to patient disease awareness education campaign. In an effort to arm patients with the knowledge that they need to discuss hypercortisolism with their physicians.

2024年，我們也推出了首次直接針對患者的疾病意識教育活動。努力讓患者了解他們需要與醫生討論皮質醇增多症的知識。

Finally, the results of our catalyst study are very powerful. The study unequivocally shows that one in four patients with difficult to control diabetes have hypercortisolism, and that treatment with a cortisol modulator dramatically improves their hyperglycemia, even all the current medications, including Ozempic and [Mounjaro], have not.

最後，我們的催化劑研究結果非常強大。該研究明確表明，四分之一的難以控制的糖尿病患者患有皮質醇增多症，而使用皮質醇調節劑治療可以顯著改善他們的高血糖症，即使所有現有的藥物，包括 Ozempic 和 [Mounjaro]，都沒有效果。

Our Q1 financial results do not reflect the tremendous patient growth our business is experiencing or what we expect for the rest of this year.

我們的第一季財務表現並未反映出我們業務正在經歷的巨大成長或我們對今年剩餘時間的預期。

Our first quarter results, specifically in January and February, were affected by insufficient capacity at our pharmacy vendor.

我們的第一季業績，特別是一月和二月的業績，受到藥局供應商產能不足的影響。

As I said on our last call, the rapid growth in our business in the second half of 2024 overwhelmed the pharmacy's operational capabilities, and these challenges persisted into this year. That said, we have seen a substantial improvement in pharmacy operations in March and April. This is translated to a record number of tablets dispensed in March and April.

正如我在上次電話會議上所說，2024 年下半年我們業務的快速成長超出了藥局的營運能力，這些挑戰一直持續到今年。話雖如此，我們看到三月和四月藥局的運作情況有了顯著改善。這意味著三月和四月的藥片分發數量創下了紀錄。

Our first quarter results were also affected by a greater portion of our business transitioning from branded Korlym to our authorized generic, which has a lower net price. As a result, our average price per tablet decreased by 13% relative to the prior year. We expect that the transition to authorized generic tablets will continue to grow this year, but that this decrement in price will be overwhelmed by an increase in the number of tablets shipped.

我們第一季的業績也受到了很大影響，因為我們的大部分業務從品牌 Korlym 轉向了淨價較低的授權仿製藥。因此，我們每片藥片的平均價格與前一年相比下降了 13%。我們預計今年向授權仿製藥的轉變將繼續增長，但價格的下降將被藥片出貨量的增加所抵消。

Please let me emphasize that all factors, including pharmacy operations and pricing impact from our authorized generic are factored into our 2025 revenue guidance.

請容許我強調一下，所有因素，包括藥局營運和我們授權仿製藥的定價影響，都已計入我們的 2025 年收入預期。

I will land where I began.

我將回到我開始的地方。

I've never been more confident in both our current and future commercial growth, and most important, our potential to help many more patients. Quorum is a great medication, but Relacorilant is even better. It will be a great option for both prescribers and patients, and I expect that our patient numbers will accelerate when it emerges. I believe that in the next three to five years, Relacorilant will generate $3 billion to $5 billion in annual revenue in hypercortisolism alone.

我對我們目前和未來的商業成長從未如此有信心，最重要的是，我們幫助更多患者的潛力。Quorum 是一種很好的藥物，但 Relacorilant 甚至更好。對於醫生和患者來說，這都是一個很好的選擇，我預計，當它出現時，我們的患者數量將會增加。我相信，未來三到五年內，Relacorilant僅在皮質醇增多症領域就能產生每年30億到50億美元的收入。

I will now turn the call over to Charlie Robb, our Chief Business Officer. Charlie.

現在我將電話轉給我們的商務長 Charlie Robb。查理。

Thanks, Sean.

謝謝，肖恩。

As was true last quarter, there's not much to report regarding our patent litigation with Teva. In December of 2023, the trial court ruled against us in our lawsuit to stop Teva from marketing a generic version of Korlym in violation of our patents. We've appealed that decision to the Federal Circuit Court of Appeals. Briefing is complete for anyone interested. The documents are available at the government's Pacer website. The Federal Circuit has still not scheduled oral argument, the earliest plausible date for which is now July, the decision issuing three or four months after that.

與上個季度一樣，關於我們與 Teva 的專利訴訟沒有太多可報告的消息。2023 年 12 月，初審法院在我們提起的訴訟中判決我們敗訴，禁止 Teva 銷售侵犯我們專利的 Korlym 仿製藥。我們已就該判決向聯邦巡迴上訴法院提出上訴。對於任何有興趣的人來說，簡報已經完成。這些文件可以在政府的 Pacer 網站上查閱。聯邦巡迴法院仍未安排口頭辯論，目前最早的合理日期是 7 月，判決將在那之後三、四個月發布。

As I've said before, we're eager to advance this appeal. We strongly believe our position is correct and that the Federal Circuit will agree with us. If we prevail, Teva will lose FDA approval of its product until 2037, when the patents we have asserted against Teva in this lawsuit expire.

正如我之前所說，我們渴望推進這項呼籲。我們堅信我們的立場是正確的，聯邦巡迴法院也會同意我們的觀點。如果我們勝訴，Teva 的產品將失去 FDA 批准，直到 2037 年，即我們在此次訴訟中針對 Teva 主張的專利到期為止。

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

現在我將電話轉給我們的執行長喬·約瑟夫·貝拉諾夫 (Joe Joseph Belanoff)。

Thank you, Charlie, and thank you everyone for joining us this afternoon. This is a very exciting time at Corcept. Our development programs have generated two profound medical findings in hypercortisolism and oncology and two potential avenues of substantial revenue growth.

謝謝你，查理，也謝謝大家今天下午加入我們。這是 Corcept 非常令人興奮的時刻。我們的開發項目在皮質醇增多症和腫瘤學方面產生了兩項重大的醫學發現，並帶來了兩個大幅收入成長的潛在途徑。

Let's focus on hypercortisolism first.

我們先來關註一下皮質醇增多症。

Our new drug application for relacorilant and hypercortisolism is based on positive results from our pivotal phase 3 GRACE trial and is supported by the results from our GRADIENT, long-term extension, and phase 2 trials. It is currently under review with an FDA action date of December 30, 2025.

我們針對 relacorilant 和皮質醇增多症的新藥申請是基於我們關鍵的 3 期 GRACE 試驗的積極結果，並得到我們的 GRADIENT、長期擴展和 2 期試驗結果的支持。目前正在接受審查，FDA 的審批日期為 2025 年 12 月 30 日。

Patients treated with [relacorilant] in these studies experienced clinically meaningful and statistically significant improvements across all of the signs and symptoms of hypercortisolism in hypertension, hyperglycemia, weight, lean muscle mass, waist circumference, cognition, Cushing's quality of life score, and other important clinical measures.

在這些研究中，接受 [relacorilant] 治療的患者在高血壓、高血糖、體重、肌肉質量、腰圍、認知、庫欣生活品質評分和其他重要臨床指標等皮質醇增多症的所有體徵和症狀方面均經歷了具有臨床意義和統計學意義的改善。

There was a high level of consistency and durability of therapeutic benefit across our studies. In each of them, patients exhibited rapid improvements at the start of [relacorilant] therapy, and these improvements were maintained or continued to improve throughout the course of treatment, including in a long-term extension study where some patients have received [relacorilant] for more than six years.

在我們的研究中，治療益處具有高度的一致性和持久性。在每項研究中，患者在開始接受 [relacorilant] 治療時均表現出快速改善，並且這些改善在整個治療過程中得以維持或持續改善，包括在一項長期延伸研究中，一些患者接受 [relacorilant] 治療已超過六年。

Just as important as relacorilant's efficacy is its safety. Relacorilant has been well tolerated in all of its studies. The most common adverse events are consistent with the cortisol withdrawal that patients with hypercortisolism experience following a rapid reduction in their cortisol activity, whether due to surgery or at the start of medical therapy.

relacorilant 的功效與安全性同樣重要。Relacorilant 在所有研究中均表現出良好的耐受性。最常見的不良事件與皮質醇戒斷症狀一致，皮質醇增多症患者在皮質醇活性迅速降低後會出現這種症狀，無論是由於手術還是在開始藥物治療時。

As expected, there have been no relicorolent induced instances of hypokalemia, endometrial hypertrophy, or drug induced vaginal bleeding, no cases of adrenal insufficiency, and no instances of QT prolongation. These adverse events can have serious health consequences. Each of the currently available medications for patients with Cushing's syndrome can cause one or more of them.

如預期的那樣，沒有出現 relicorolent 引起的低血鉀、子宮內膜肥大或藥物引起的陰道出血的情況，沒有腎上腺功能不全的情況，也沒有出現 QT 延長的情況。這些不良事件可能會造成嚴重的健康後果。目前用於治療庫欣氏症候群患者的每種藥物都可能導致一種或多種症狀。

As we advance relacorilant, we continue to work at increasing physician awareness and understanding of hypercortisolism.

隨著我們推進 relacorilant 的發展，我們將繼續致力於提高醫生對皮質醇增多症的認識和理解。

Our catalyst study was the largest and most rigorous trial ever conducted to assess the prevalence and treatment of hypercortisolism in patients with difficult to control type 2 diabetes. The prevalence phase of the study found that one in four patients with difficult to control type 2 diabetes has hypercortisolism.

我們的催化劑研究是迄今為止規模最大、最嚴格的試驗，旨在評估難以控制的 2 型糖尿病患者的皮質醇增多症的盛行率和治療方法。流行階段的研究發現，四分之一的難以控制的 2 型糖尿病患者患有皮質醇增多症。

A far higher rate than was assumed.

這一比率遠高於預期。

These results were published last month in Diabetes Care, a peer-reviewed journal of the American Diabetes Association.

這項結果上個月發表在美國糖尿病協會的同行評審期刊《糖尿病照護》。

The results from the treatment phase of the Catalyst study were equally striking.

Catalyst 研究的治療階段的結果同樣引人注目。

Patients who receive Korlym exhibited a large reduction, 1.47% in hemoglobin A1C, a key measure of glucose control compared to a 0.15% decrease in patients who receive placebo, a P value of less than 0.0001. The magnitude of reduction seen in the treatment arm is especially striking given that these patients were already receiving multiple glucose lowering therapies, including the most potent GLP-1 agonists. Results from the treatment phase of Catalyst will be presented at a keynote session at the American Diabetes Association's annual scientific sessions next month.

接受 Korlym 治療的患者的糖化血紅蛋白 (A1C)（血糖控制的關鍵指標）大幅降低 1.47%，而接受安慰劑治療的患者則降低 0.15%，P 值小於 0.0001。考慮到這些患者已經接受多種降血糖療法，包括最有效的 GLP-1 激動劑，治療組中看到的降低幅度尤其引人注目。Catalyst 治療階段的結果將於下個月在美國糖尿病協會年度科學會議的主題演講中公佈。

A rapidly increasing number of physicians now know that hypercortisolism is much more prevalent than was previously assumed. They are screening and treating many more patients than ever before. The findings from Catalyst, once they are more broadly known, will undoubtedly stimulate even more doctors to screen for hypercortisolism. Many more patients with hypercortisolism than are currently identified will be found. Corcept is well positioned to help them. As Sean said earlier, we are confident that our Cushing's syndrome business will continue to grow for years.

現在，越來越多的醫生認識到皮質醇增多症比以前認為的更為普遍。他們篩檢和治療的患者比以往任何時候都多。Catalyst 的研究結果一旦得到更廣泛地宣傳，無疑將刺激更多的醫生篩檢皮質醇增多症。將會發現比目前確診的多得多的皮質醇增多症患者。Corcept 完全有能力幫助他們。正如肖恩之前所說，我們相信我們的庫欣氏症候群業務將在未來幾年持續成長。

Since the founding of Corcept, our research and development efforts have been built on the hypothesis that cortisol modulation is a powerful therapeutic mechanism in many serious disorders. The success of our pivotal ROSELLA trial in platinum resistant ovarian cancer is tangible proof of the therapeutic value of cortisol modulation and highlights the potential of this mechanism of action to be broadly useful.

自 Corcept 成立以來，我們的研發工作一直建立在這樣的假設之上：皮質醇調節是許多嚴重疾病的強大治療機制。我們在鉑耐藥性卵巢癌中的關鍵 ROSELLA 試驗的成功，有力地證明了皮質醇調節的治療價值，並凸顯了這種作用機制的廣泛應用潛力。

In ROSELLA, 381 women with platinum resistant ovarian cancer were randomized one to one to receive either Nab-paclitaxel, probably the most effective chemotherapy currently prescribed to women with platinum resistant disease, or nab-paclitaxel plus relacorilant. For these patients, nab-paclitaxel or any chemotherapy have become much less useful than earlier in their course of treatment.

在 ROSELLA 研究中，381 名患有鉑耐藥性卵巢癌的女性被一對一隨機分配接受白蛋白結合型紫杉醇治療（可能是目前針對鉑耐藥性卵巢癌女性最有效的化療方案）或白蛋白結合型紫杉醇聯合雷科瑞林治療。對於這些患者來說，白蛋白結合型紫杉醇或任何化療藥物的作用都比治療初期小得多。

We expected that relacorilant would re-sensitize ovarian tumors to the effects of nab-paclitaxel by blunting the anti-apoptotic effect of cortisol activity.

我們預計，relacorilant 會透過減弱皮質醇活性的抗凋亡作用，使卵巢腫瘤重新對白蛋白結合型紫杉醇的作用敏感。

The ROSELLA trial met its primary endpoint of improved progression free survival as assessed by blinded independent central review.

ROSELLA 試驗達到了其主要終點，即透過盲法獨立中央審查評估改善無惡化存活期。

Patients treated with relacorilant, in addition to nab-paclitaxel chemotherapy, experienced a 30% reduction in risk of disease progression compared to patients treated with nab-paclitaxel alone with a hazard ratio of 0.70 and a P value of 0.008.

與單獨接受 nab-紫杉醇治療的患者相比，接受 relacorilant 合併 nab-紫杉醇化療治療的患者病情進展風險降低了 30%，風險比為 0.70，P 值為 0.008。

In the interim evaluation of overall survival, patients treated with relacorilant plus nab-paclitaxel showed a large improvement, with a median over overall survival of 16 months compared to 11.5 months in patients receiving nab-paclitaxel alone.

在總存活期的中期評估中，接受 relacorilant 加白蛋白紫杉醇治療的患者顯示出了很大的改善，中位總生存期為 16 個月，而單獨接受白蛋白紫杉醇治療的患者為 11.5 個月。

The hazard ratio was 0.69 with a P value of 0.01.

風險比為0.69，P值為0.01。

Safety and tolerability were comparable in the two groups.

兩組的安全性和耐受性相當。

ROSELLA clearly confirmed the positive efficacy and safety results that we saw in our phase 2 study.

ROSELLA 明確證實了我們在第二階段研究中看到的正面功效和安全性結果。

The full results of the ROSELLA study will be presented at an oral late breaker session at the American Society of Clinical Oncology's annual meeting next month.

ROSELLA 研究的完整結果將於下個月在美國臨床腫瘤學會年會的口頭報告會議上公佈。

We expect to submit relacorilant's NDA and platinum resistant ovarian cancer next quarter, and a marketing authorization application in Europe shortly thereafter.

我們預計將於下個季度提交 relacorilant 的 NDA 和鉑類抗藥性卵巢癌，並在不久後提交歐洲的營銷授權申請。

In anticipation of a successful regulatory outcome, we've been building a stand-alone oncology division. We are fully prepared to move swiftly to bring relacorilant plus nab-paclitaxel to the woman who can benefit from it once it is approved.

為了獲得成功的監管結果，我們一直在建立一個獨立的腫瘤學部門。一旦獲得批准，我們已做好充分準備迅速採取行動，將 relacorilant 加白蛋白結合型紫杉醇帶給女性，讓她們從中受益。

We expect to expand the findings from ROSELLA with our recently initiated BELLA study which will examine whether relacorilant with two medications, nab-paclitaxel and bevacizumab will offer patients with platinum resistant ovarian cancer an additional effective treatment regimen.

我們希望透過最近啟動的 BELLA 研究來擴展 ROSELLA 的研究成果，該研究將檢查 relacorilant 與兩種藥物（白蛋白結合型紫杉醇和貝伐單抗）是否能為鉑耐藥性卵巢癌患者提供額外的有效治療方案。

We will then explore relacorilant use to help treat earlier stages of ovarian cancer and other solid tumors that express the glucocorticoid receptor.

然後，我們將探索使用 relacorilant 來幫助治療早期卵巢癌和其他表達糖皮質激素受體的實體腫瘤。

In addition to exploring cortisol modulation's potential to re-sensitize tumors to chemotherapy, we are evaluating its potential use in combination with androgen deprivation therapy and prostate cancer. Cortisol stimulation is a major reason why patients with prostate cancer treated with the widely prescribed androgen receptor antagonist enzalutamide eventually experience surge and disease. Deprived of androgen stimulation, their tumors switched to cortisol activity to stimulate growth.

除了探索皮質醇調節使腫瘤對化療重新敏感的潛力之外，我們還在評估其與雄激素剝奪療法和前列腺癌聯合治療的潛在用途。皮質醇刺激是使用廣泛使用的雄性激素受體拮抗劑恩雜魯胺治療的前列腺癌患者最終出現激增和疾病的主要原因。由於缺乏雄性激素刺激，他們的腫瘤轉而利用皮質醇活性來刺激生長。

Leading academic researchers and clinicians hypothesized that cortisol modulation can block this tumor escape route.

領先的學術研究人員和臨床醫生假設皮質醇調節可以阻止這種腫瘤逃脫路線。

Our collaborators at the University of Chicago are currently enrolling a randomized placebo-controlled phase 2 trial of Relacorilant plus enzalutamide in patients with early-stage prostate cancer before these patients have had an initial [prostatectomy].

我們在芝加哥大學的合作者目前正在招募一項隨機安慰劑對照的 2 期臨床試驗，試驗對象為早期前列腺癌患者，試驗對象為尚未接受初次治療的患者。[攝護腺切除術]

Another possible role of cortisol modulation is in combination with immunotherapy.

皮質醇調節的另一個可能作用是與免疫療法結合。

Because cortisol suppresses the immune system, it may blunt the effectiveness of cancer therapies intended to stimulate an immune response.

由於皮質醇會抑制免疫系統，它可能會削弱旨在刺激免疫反應的癌症療法的有效性。

Adding a cortisol modulator to immunotherapies, such as checkpoint inhibitors may enhance their effectiveness.

在免疫療法中添加皮質醇調節劑（例如檢查點抑制劑）可能會增強其有效性。

Following our phase 1b trial on advanced adrenal cancer, we are deciding how best to investigate the utility of our compounds in combination with immunotherapies and other tumor types and earlier stages of cancer.

在對晚期腎上腺癌進行 1b 期試驗之後，我們正在決定如何最好地研究我們的化合物與免疫療法以及其他腫瘤類型和早期癌症相結合的效用。

One of our proprietary compounds, dazucorilant, readily crosses the blood-brain barrier and is a candidate for the treatment of neurologic disorders.

我們的專有化合物之一達珠可利特 (dazucorilant) 能夠輕鬆穿過血腦屏障，是治療神經系統疾病的候選藥物。

Based on compelling data showing improved motor performance and reduced neural inflammation and muscular atrophy in a commonly used mouse model of ALS, we conducted a 249 patient randomized double blind placebo controlled phase 2 trial of dazucorilant in that dire disease.

基於令人信服的數據，該數據表明常用的 ALS 小鼠模型的運動能力得到改善，神經發炎和肌肉萎縮得到減少，我們對 249 名患者進行了一項隨機雙盲安慰劑對照的 2 期臨床試驗，以測試達珠可林對這種可怕疾病的療效。

Unfortunately, patients who received dazucorilant did not show improvement in the ALS function functional rating scale revised the study's primary endpoint.

不幸的是，接受達祖可林治療的患者在 ALS 功能評估量表（修訂了研究的主要終點）中並未表現出改善。

However, an improvement in overall survival first seen at the six month mark, was also observed at year one of the study. An exploratory analysis showed that patients who were randomized to 300 mg of dazucorilant at the start of the study.

然而，在研究的第一年也觀察到了在六個月時首次出現的總體存活率的提高。探索性分析表明，在研究開始時隨機分配服用 300 毫克達珠可利特的患者。

With significantly longer than patients who were randomized to placebo and then did not switch to dazucorilant in the long-term extension study with a hazard ratio of 0.16, a P value of 0.0009.

在長期延長研究中，其風險比為 0.16，P 值為 0.0009，明顯長於隨機接受安慰劑治療但未改用達珠可利特的患者。

We will immediately seek input from US and European regulatory authorities on the next steps for this program.

我們將立即向美國和歐洲監管機構尋求有關該計劃下一步行動的意見。

MASH metabolic dysfunction associated to the hepatitis is a serious liver disorder that afflicts millions of patients in the United States and many millions outside the United States.

與肝炎相關的 MASH 代謝功能障礙是一種嚴重的肝臟疾病，困擾著美國數百萬名患者以及美國以外數百萬患者。

Cortisol activity plays a role in both the initial development and progression of the disease, and cortisol modulation may serve as a treatment.

皮質醇活動在疾病的初始發展和進展中都發揮作用，皮質醇調節可以作為一種治療方法。

One of our proprietary molecules, miricorilant, has very potent activity in the liver. Our phase 1b dose finding study of miricorilant found that patients who receive 100 mg orally just twice a week for 12 weeks experienced a 30% reduction in liver fat, and improvement in liver enzymes, markers of fibrosis, and key metabolic and lipid measures such as insulin resistant, serum triglycerides, and LDL.

我們的專有分子之一 miricorilant 在肝臟中具有非常強的活性。我們對米利可蘭進行的 1b 期劑量探索研究發現，每週口服兩次 100 毫克，持續 12 週的患者肝臟脂肪減少 30%，肝酵素、纖維化標記物以及胰島素抗性、血清三酸甘油酯和 LDL 等關鍵代謝和脂質指標均得到改善。

Miricorilant was also very well tolerated, with none of the GI side effects which commonly arise in patients being treated for MASH.

Miricorilant 的耐受性也非常好，沒有出現接受 MASH 治療的患者常見的胃腸道副作用。

Our randomized double blind placebo-controlled phase 2b MONARCH study aims to expand on our encouraging phase 1b results. MONARCH is enrolling two cohorts. In the first, patients with biopsy confirmed [Mash] are randomized 2:1 to receive either 100 mg of Miricorilant twice weekly or placebo for 48 weeks. The primary endpoint for this cohort is reduction in liver fat, with biopsy confirmed mash resolution and fibrosis improvement as key secondary endpoints.

我們的隨機雙盲安慰劑對照 2b 期 MONARCH 研究旨在擴展我們令人鼓舞的 1b 期結果。MONARCH 正在招收兩個批次的學生。首先，經活檢確診為 [Mash] 的患者以 2:1 的比例隨機分配接受每週兩次 100 毫克 Miricorilant 或安慰劑治療，持續 48 週。此族群的主要終點是肝臟脂肪的減少，切片證實的肉芽腫消退和纖維化的改善是關鍵的次要終點。

The second cohort is enrolling patients with presumed MASH.

第二組正在招募疑似患有 MASH 的患者。

Patients in this cohort will be randomized 2:1 to receive either 100 mg Miricorilant twice weekly for six weeks, followed by 200 mg of Miricorilant twice weekly for 18 weeks or placebo for the whole 24 weeks. In this cohort, the primary endpoint is also a reduction in liver fat.

該組患者將以 2:1 的比例隨機分配接受以下治療：每週兩次服用 100 毫克 Miricorilant，持續六週；然後每週兩次服用 200 毫克 Miricorilant，持續 18 週；或接受安慰劑治療，持續 24 週。在這個族群中，主要終點也是肝臟脂肪的減少。

As I said earlier, this is a truly exciting time at Corcept. We have made substantial progress throughout the company and have established two potent drivers of long-term growth in entirely different areas of medicine, endocrinology and oncology.

正如我之前所說，這是 Corcept 真正令人興奮的時刻。我們在整個公司範圍內取得了實質的進展，並在完全不同的醫學領域——內分泌學和腫瘤學——建立了兩個強大的長期成長驅動力。

Awareness of hypercortisolism's true prevalence continues to grow rapidly. More patients are being identified and treated than ever before. The results of the Catalyst study will undoubtedly stimulate more physicians to screen for hypercortisolism and treat the patients that they identify.

人們對皮質醇增多症真實盛行率的認識持續快速成長。確診和治療的患者比以往任何時候都多。Catalyst 研究的結果無疑將激勵更多的醫生篩檢皮質醇增多症並治療他們發現的患者。

Our new drug application for Relacorilant and hypercortisolism is progressing towards approval by the end of this year.

我們針對 Relacorilant 和皮質醇增多症的新藥申請正在爭取在今年年底前獲得批准。

Relacorilant's strong efficacy and safety profile gives it the potential to become the new standard of care for patients with hypercortisolism. We expect our Cushing's syndrome business to continue growing for years to come.

Relacorilant 的強大功效和安全性使其有可能成為皮質醇增多症患者的新治療標準。我們預計庫欣氏症候群業務在未來幾年將繼續成長。

The positive results of our ROSELLA study opens Corcept's oncology portfolio. The efficacy benefits observed in the context of no increased side effect burden support a successful new drug application for platinum resistant ovarian cancer and create with further study the potential to treat earlier stages of ovarian cancer and other tumors that express the glucocorticoid receptor.

我們的 ROSELLA 研究的積極成果開闢了 Corcept 的腫瘤學產品組合。在不增加副作用負擔的情況下觀察到的療效益處支持了鉑耐藥性卵巢癌新藥的成功應用，並通過進一步研究創造了治療早期卵巢癌和表達糖皮質激素受體的其他腫瘤的潛力。

In addition, we continue to explore the potential of cortisol modulation to treat a broad range of diseases, including neurologic diseases like ALS and [hepatic] diseases. We continue to develop and discover proprietary selective [cortisol] modulators with potentially very distinct clinical attributes. We are comprehensively evaluating these attributes in their therapeutic applications and will advance the most promising compounds to the clinic.

此外，我們將繼續探索皮質醇調節治療多種疾病的潛力，包括 ALS 等神經系統疾病和[肝臟]疾病。我們繼續開發和發現具有潛在非常獨特的臨床屬性的專有選擇性[皮質醇]調節劑。我們正在全面評估這些屬性在治療應用中的效果，並將最有前景的化合物推向臨床。

Problems caused by excess cortisol activity often have profoundly negative effects on patients. We are dedicated to finding new, more effective, and safer treatments to help them.

皮質醇活動過多引起的問題通常會對患者產生嚴重的負面影響。我們致力於尋找新的、更有效、更安全的治療方法來幫助他們。

Operator, let's proceed now to questions.

接線員，我們現在開始提問。

Thank you.

謝謝。

(Operator Instructions)

（操作員指示）

Edward Nash, Canaccord. Your line is open, Edward.

愛德華·納什（Edward Nash），Canaccord。你的線路已開通，愛德華。

Hi, thanks guys for taking my question. Wanted to ask, specifically on the oncology program. You have ROSELLA under your belt now, and now you've started BELLA. I just wanted to understand from the treatment paradigm side of things, exactly where would the physicians start to employ and start to use Relacorilant versus say [ELAHERE]? How would that, how does that in any way push [ELAHERE] here forward or back within the treatment paradigm? And then also, could you just give us any clarity or any granularity you have on the feedback you've been getting from oncologists based on the ROSELLA data?

嗨，謝謝大家回答我的問題。想問一下，特別是關於腫瘤學課程。現在你已經擁有了 ROSELLA，並且又創辦了 BELLA。我只是想從治療模式的角度來了解，醫生究竟該在哪裡開始使用 Relacorilant，而不是說[埃拉赫爾]？那將如何、如何以任何方式推動 [ELAHERE] 在治療範式中前進或後退？另外，您能否根據 ROSELLA 數據向我們詳細說明您從腫瘤學家那裡得到的回饋？

Yeah, hey Edward, thank you, and that's a great opening question because it gives me a chance to introduce for the first time on this call Roberto Vieira, who is the President of our oncology division. I think he has the answers for both of those questions. Please go ahead, Roberto.

是的，嘿愛德華，謝謝你，這是一個很好的開場問題，因為它讓我有機會在這次電話會議上第一次介紹我們的腫瘤科總裁羅伯托維埃拉。我認為他對這兩個問題都有答案。請繼續，羅伯托。

Thank you, Joe. So [Matt], several questions into one there. So as far as our view for Relacorilant , Relacorilant that was poised to become a new standard of care in platinum reducing ovarian cancer.

謝謝你，喬。那麼[Matt]，幾個問題合併成一個。就我們對 Relacorilant 的看法而言，Relacorilant 有望成為鉑類治療卵巢癌的新標準治療方法。

When you look at the treatment patterns, you see a very fragmented landscape. So most patients have limited options and suffer with very poor outcomes. So we feel confident Relacorilant play another cell sets the foundation for a new standard of care. Now concerning your question about [ELAHERE] and positioning, the results from the ROSELLA trials support Relacorilant as an option in multiple lines of therapy, including before or after a biomarker ridden agent such as [ELAHERE] here.

當你觀察治療模式時，你會看到非常分散的景象。因此大多數患者的選擇有限，且治療效果很差。因此，我們相信 Relacorilant 在另一個細胞中發揮的作用將為新的護理標準奠定基礎。現在關於您關於 [ELAHERE] 和定位的問題，ROSELLA 試驗的結果支持將 Relacorilant 作為多種療法的一種選擇，包括在生物標記驅動的藥物（例如此處的 [ELAHERE]）之前或之後使用。

Great, that's very helpful.

太好了，這非常有幫助。

Thank you. And then I just had one additional question that was just in the revenue given that it sounds like March and April, you really think really picked up significantly after the correction was made. Just wanted to understand how that's going to affect the third, the second, third and fourth quarters. Are we going to expect to see a huge [bolus] in the second quarter in revenue and then Things kind of get back down to a normal level or just wanted to better understand how to model for that.

謝謝。然後我還有一個問題，那就是考慮到聽起來像三月和四月的收入，你真的認為在進行修正後收入確實大幅回升。只是想了解這將如何影響第三季、第二季、第三季和第四季。我們是否會預期第二季的收入會大幅成長，然後情況會恢復到正常水平，或者只是想更好地了解如何對此進行建模。

Yeah, I think we understand the question, and I'm going to Edward, reintroduce you to Sean Maduck, who is the President of our endocrinology vision.

是的，我想我們明白了這個問題，我將向愛德華重新介紹肖恩·馬達克 (Sean Maduck)，他是我們內分泌學願景的總裁。

Yeah, thanks, Ed. So I'll start by saying that, as I sort of ended my opening remarks on the fundamentals of our business are extremely strong and really strengthened in the fourth quarter of last year into Q1, and we do expect that through the rest of the year and We had a record number of prescribers, prescriptions, and patients on call to end the quarter, and as you know you've seen our first quarter of financial results did not match the strength of the business due to everything I mentioned on the call. But to your question, I mean, we expect the growth to continue through the second quarter and the rest of the year and actually accelerate in the half of the second half of the year given. All the initiatives we have on the commercial side as well as the publication of the full Catalyst data results. So very excited about it and more confident than ever that the market is bigger than we once thought and that we're on track for a range of $900 million to $950 million.

是的，謝謝，埃德。因此，首先我想說的是，正如我在開場白中所說的那樣，我們業務的基本面非常強勁，並且在去年第四季度和第一季度得到了真正的加強，我們確實預計今年剩餘時間的情況也將如此，到本季度末，我們的處方人員、處方和待命患者數量都創下了歷史新高，正如您所知，由於我在電話成績中提到的所有權力。但對於您的問題，我的意思是，我們預計成長將持續到第二季​​和今年剩餘時間，並且實際上在下半年會加速。我們在商業方面的所有舉措以及完整 Catalyst 數據結果的發布。我們對此感到非常興奮，並且比以往任何時候都更有信心，市場比我們曾經想像的要大，而且我們有望達到 9 億至 9.5 億美元的目標。

Edward, to answer your question directly, yeah, we're not expecting an instant [bolus]. We just think that growth will accelerate through the entire year and then into the next year.

愛德華，直接回答你的問題，是的，我們不期待立即[丸]。我們只是認為，成長將會在全年乃至明年加速。

Got it. Okay.

知道了。好的。

That makes sense. Thanks so much for taking the questions and also congratulations on that dazzle overall survival data.

這很有道理。非常感謝您回答這些問題，同時也祝賀您獲得如此令人眼花繚亂的整體生存數據。

Thanks Edward. Thanks very much for the questions.

謝謝愛德華。非常感謝您的提問。

David Amsellem, Piper Jaffray, please go ahead, David.

David Amsellem，Piper Jaffray，請繼續，David。

Hey, thanks, so, got a Korlym question and then a couple of Relacorilant questions on Korlym. Can you talk about the mix between brand and authorized generic business for Korlym as the year progresses, and I guess is it fair to say that irrespective of that mix between the AG. And the brand, this acceleration and volume growth and this expansion of the market that we're seeing ultimately is what gets you to that $900 million to $950 million. So that's my first question. And then on Relacorilant, just two quick ones, just remind us if you are expecting an ad com going into the December [PDUFA], and are you preparing for one. And then when are we going to hear more about additional solid tumor studies for Relacorilant presumably you're going to look at potentially earlier lines of therapy and ovarian, other solid tumors. When are we going to get more details on your overall solid tumor strategy?

嘿，謝謝，所以，我有一個關於 Korlym 的問題，然後還有幾個關於 Korlym 的 Relacorilant 的問題。您能否談談 Korlym 隨著時間的推移在品牌業務和授權仿製藥業務之間的組合情況，我想，無論 AG 之間的組合如何，這樣說是否公平。而我們最終看到的品牌、加速和銷售成長以及市場擴張將使你的銷售額達到 9 億至 9.5 億美元。這是我的第一個問題。然後關於 Relacorilant，我只想快速問兩個問題，請提醒我們，您是否預計 12 月 [PDUFA] 會有廣告發布會，並且您是否正在為此做準備。那麼，我們什麼時候才能聽到更多關於 Relacorilant 的額外實體瘤研究的消息，大概你會研究潛在的早期治療方法和卵巢腫瘤以及其他實體瘤。我們什麼時候才能獲得有關您的整體實體瘤策略的更多詳細資訊？

Thank you.

謝謝。

Thank you, David. And yes, you've give us give us an opportunity for several people to respond to your various questions. So, Sean, why don't you take the first question about Korlym?

謝謝你，大衛。是的，您給了我們一個機會，讓我們的幾個人來回答您的各種問題。那麼，肖恩，你為什麼不回答關於科林的第一個問題呢？

Yeah, thanks for the question. So, your last statement and the first part of the question on Korlym is exactly it, and that's that we expect that future volume growth will overwhelm any price change that we see, given the mix of products. So, the first part of the question, what's the mix? Of Korlym and our authorized generic, a little over half right now of our product, our patients are on our authorized generic. We expect that that percentage will continue to increase over the course of the year and we factor that into our guides.

是的，謝謝你的提問。因此，您的最後陳述和有關 Korlym 的問題的第一部分正是如此，那就是考慮到產品組合，我們預計未來的銷售成長將壓倒我們看到的任何價格變化。那麼，問題的第一部分是，混合是什麼？在 Korlym 和我們授權的仿製藥中，目前有一半以上的產品，我們的患者都在使用我們授權的仿製藥。我們預計該百分比將在今年繼續增加，並且我們已將其納入我們的指南中。

Charlie.

查理。

Yes, we do not expect to have an advisory committee.

是的，我們不希望設立諮詢委員會。

Didn't have one for Korlym. The most recently approved drugs in hypercortisolism didn't have them either, and we're not anticipating one here.

沒有適合 Korlym 的。最近核准的治療皮質醇增多症的藥物也沒有這種成分，我們在這裡也不期望出現這種成分。

Okay, and Bill, could you please answer the last question about other tumors.

好的，比爾，你能回答關於其他腫瘤的最後一個問題嗎？

So you know it's really been on our minds for quite some time to look at Relacorilant in combination with any therapy in solid tumors, and it's based upon our phase 1, phase 2, and now with the phase 3 results we have taken something from a concept to a reality, and we're now going to be hopefully rapidly expanding into that. And so, our goal is to really establish Relacorilant as the foundation. Drug to be used in combination with any agent in solid tumors. And so, BELLA is at first foray into that next study in the earlier lines of therapy in combination now with [nab-paclitaxel] and bevacizumab. You'll shortly see later this year and as you had indicated, we're going to go to earlier lines of ovarian cancer and then also expand into other gynecological oncology cancers and then soon after that go into longer term into other solid tumors, so.

所以你知道，我們確實已經在考慮將 Relacorilant 與任何實體瘤療法相結合，這是基於我們的第 1 階段、第 2 階段的結果，現在，根據第 3 階段的結果，我們已經將一些概念變成了現實，現在我們希望能夠迅速擴展到這一領域。因此，我們的目標是真正將 Relacorilant 確立為基礎。與任何治療實體瘤的藥物合併使用的藥物。因此，BELLA 首次嘗試對早期療法進行下一項研究，目前與 [nab-paclitaxel] 和貝伐單抗聯合使用。您很快就會在今年稍後看到，正如您所說，我們將研究早期卵巢癌，然後擴展到其他婦科腫瘤癌症，隨後不久將研究長期其他實體腫瘤。

You're going to see many new studies coming, but again all geared around Relacorilant is that core molecule in combination with any agent.

您將會看到許多新的研究，但所有這些研究都圍繞著 Relacorilant 展開，它是與任何藥劑相結合的核心分子。

Okay, next question.

好的，下一個問題。

Sure, thank you.

當然，謝謝。

Thank you.

謝謝。

Joon Lee, Truist Securities.

Joon Lee，Truist Securities。

Thanks for the updates and for taking our questions.

感謝您提供最新消息並回答我們的問題。

Can you help us understand the nature of the corrective measures the pharmacy vendor took to improve operations in March and April, and what, if anything, more needs to be done to for them to be able to meet the demands so you can hit the guidance of $900 million to $950 million and I have a follow-up question.

您能否幫助我們了解藥房供應商在 3 月和 4 月為改善營運而採取的糾正措施的性質，以及他們還需要做哪些工作才能滿足需求，從而達到 9 億至 9.5 億美元的指導目標，我有一個後續問題。

Thanks, June, and I'll give you back to Sean to answer your question.

謝謝，瓊，我會把答案交給肖恩來回答你的問題。

Thanks for the question. And again, in case anybody didn't get a chance to listen to the opening remarks, the issue that's being referenced at the pharmacy is really through the fourth quarter of last year through February of this year, there was really a massive prescription volume increase that sort of overwhelmed the pharmacy. So, in general, there were some, I won't go into all the specifics, but There were some staffing issues associated with enough individuals to pull through all the appropriate volume, and because of that, patients' prescriptions weren't filled on time. That has been remedied. It's been staffed up and I'll just point to again having the strongest March 2 of the strongest months, to the two strongest months we've ever had in our history in March and April, and we expect that the pharmacy will continue to scale up with our growth going forward.

謝謝你的提問。再說一次，如果有人沒有機會聽到開場白，那麼藥房提到的問題實際上是從去年第四季到今年 2 月，處方量大幅增加，藥房不堪重負。因此，總的來說，存在一些問題，我不會談論所有細節，但是存在一些人員配備問題，沒有足夠的人員來完成所有適當的配藥量，因此，患者的處方沒有按時配齊。該問題已修正。它已經配備了人員，我只想再次指出，我們迎來了最強勁的月份中的 3 月 2 日，以及我們歷史上最強勁的兩個月份（3 月和 4 月），我們預計藥房規模將隨著我們未來的增長而繼續擴大。

And then, with the measures that they're taking to staff up, I mean, would you, would they be able to meet the demand of Relacorilant, which we think could be a much bigger product, and I a follow up last question after that.

然後，透過他們正在採取的人員增加措施，我的意思是，他們是否能夠滿足 Relacorilant 的需求，我們認為這可能是一個更大的產品，之後我會繼續問最後一個問題。

Yeah, no, it's a great question and something we're exploring. I mean, I'll remind you that the reason we have such a narrow distribution network for Korlym is because the active ingredient in Korlym is mifepristone, and it was originally set up. To make sure there was no product aversion for termination of pregnancy or other uses. Now Relacorilant obviously doesn't have that same issue, and we do expect that the market is potentially much larger. So, there is the potential for a broader distribution network for that product, and that's something that we're actively exploring now.

是的，不，這是一個很好的問題，我們正在探索。我的意思是，我要提醒你，我們 Korlym 的分銷網絡如此狹窄的原因是因為 Korlym 中的活性成分是米非司酮，而且它最初就是這麼設立的。確保不存在因終止懷孕或其他用途而產生的產品厭惡。現在 Relacorilant 顯然不再存在同樣的問題，而且我們確實預計其市場潛力會更大。因此，該產品有可能擁有更廣泛的分銷網絡，這也是我們現在正在積極探索的事情。

Right. And last question regarding the ALS, is it your expectation that the existing data may be adequate for some sort of conditional approval, or are you anticipating some sort of additional study to get this [especiallyally] transformative a drug out there.

正確的。關於 ALS 的最後一個問題，您是否預期現有數據足以獲得某種有條件的批准，或者您是否預計需要進行某種額外的研究才能讓這種（尤其是）變革性的藥物上市。

Thank you.

謝謝。

Hey Joon, thank you for the question. I'm going to give that to Charlie who runs our regulatory area.

嘿，俊，謝謝你的提問。我要把它交給負責我們監理領域的查理。

So, the question with data like this, we confronted the exact same questions and that's why we're going immediately to both the US and European regulators to sort of present them with the plans for further study and see what they think the appropriate. Step is in terms of, moving the drug forward whether that's an accelerated approval or rapid completion of another study or something else. So, I don't want to speak to what the regulators are going to say, but we think these data are obviously promising and worth that discussion. And once we've settled things, we'll let folks know.

因此，對於此類數據的問題，我們也面臨著完全相同的問題，這就是為什麼我們要直接向美國和歐洲監管機構提出進一步研究的計劃，看看他們認為什麼是合適的。步驟是指推動藥物向前發展，無論是加速批准還是快速完成另一項研究或其他什麼。所以，我不想談論監管機構會說什麼，但我們認為這些數據顯然是有希望的，值得討論。一旦我們解決了問題，我們就會通知大家。

Thank you.

謝謝。

Thank you, Joon.

謝謝你，俊。

Thank you. Our next question comes from the line of RK of H.C. Wainwright. Please go ahead.

謝謝。我們的下一個問題來自 H.C. RK。溫賴特。請繼續。

Thank you, good afternoon, Joe. A couple of quick questions on Korlym and from me too, so in the opening remarks you said there was a significant increase in scripts that you saw got filled in March and April. I know you won't be able to tell me the exact numbers, but in general, what's a, what is that percentage increase as compared to like January and February. And then, when you say that you know 50% of your patients are moving towards, authorized generics, so yeah, I'm just trying to understand like what's the price differential between the Korlym and authorized generic and the I'm trying to triangulate between that and the and the increase in the scripts to get to, your stated, 30% increase in revenue year over year.

謝謝，下午好，喬。有幾個關於 Korlym 的快速問題，我也問了幾個，所以在開場白中您說 3 月和 4 月填寫的腳本數量顯著增加。我知道你無法告訴我確切的數字，但總的來說，與一月和二月相比，百分比增加了多少。然後，當您說您知道 50% 的患者正在轉向授權仿製藥時，是的，我只是想了解 Korlym 和授權仿製藥之間的價格差異是多少，我試圖在它和處方藥的增長之間進行三角測量，以達到您所說的收入同比增長 30%。

Yeah, I really do think we understand your question, RK.

是的，我確實認為我們理解你的問題，RK。

Thank you, and I'm going to give you back to Sean to give you a broad answer to that question.

謝謝，我會把這個問題的答案交給肖恩，讓他大致回答。

Yeah, thanks for the question. So, the first question was just around volume and volume increase. I mean our first quarter enrollments were almost double what they were in the first quarter of last year, and we've seen that continue on. So, a lot of growth driven by more screening. We're starting. See the impact of the catalyst results, and we expect with the publication of the catalyst treatment results in the second half of the year again we expect to see that growth to accelerate. So that's the first question. The second question around the authorized generic as a reminder we price our authorized generic at a 12% discount from quorum but recognized that the pairs negotiate from there as they do with sort of any list price. So. Net price varies by payer and again, the increased erosion that we expect to see over time as well as that price, we expect to be overwhelmed by volume through the course of 2025 and all of that is included in our range.

是的，謝謝你的提問。因此，第一個問題只是關於音量和音量增加。我的意思是，我們第一季的入學人數幾乎是去年第一季的兩倍，而且我們看到這種趨勢還在繼續。因此，更多的篩檢推動了很大程度的成長。我們開始了。看看催化劑結果的影響，我們預計隨著下半年催化劑處理結果的再次公佈，我們預計成長將加速。這是第一個問題。第二個問題是關於授權仿製藥的，提醒一下，我們的授權仿製藥的價格比法定價格低 12%，但我們認識到，雙方會從那裡開始談判，就像他們對任何標價所做的那樣。所以。淨價因付款人而異，而且，我們預計隨著時間的推移，侵蝕程度會增加，價格也會隨之上漲，我們預計到 2025 年，產量將超過價格，所有這些都包含在我們的範圍內。

Okay, did you have a follow-up question?

好的，您還有其他問題嗎？

Okay, it sounds like we have had a last question, but I would just like to take a minute. I don't do this often, but I think it's just important sort of speaking at this juncture. I have to admit that in the many years that I've run Corcept, I've considered lots of problems and must admit to you that I did not anticipate that our Korlym business would overwhelm our pharmacy vendor. Obviously the pro this problem set of problems had a short-term impact on our revenues, but more important, it delayed drug shipments to patients, which is inexcusable and I guess to some degree for whatever it's worth, I apologize to any patients who were you know terribly inconvenienced by this.

好的，聽起來我們好像已經問了最後一個問題，但我只想花一點時間。我並不常這樣做，但我認為在這種時刻發表這樣的言論是很重要的。我必須承認，在我經營 Corcept 的這麼多年裡，我考慮過很多問題，並且必須向你承認，我沒有預料到我們的 Korlym 業務會壓垮我們的藥房供應商。顯然，這一系列問題對我們的收入產生了短期影響，但更重要的是，它延遲了向患者運送藥品，這是不可原諒的，我想在某種程度上，無論它的價值如何，我都向所有因此而受到極大不便的患者表示歉意。

As Sean stated, the problem appears resolved. March and April were very strong months, and I have to now tell you, of course, as a result, we're intensely vigilant that this problem did not arise again. But I really want to focus you on three things which I think are real shifts in what's going on at Corcept.

正如肖恩所說，問題似乎已經解決。三月和四月是業績非常強勁的月份，我現在必須告訴你們，當然，因此，我們高度警惕，以確保這個問題不會再次出現。但我真正想讓你們專注的是三件事，我認為這三件事是 Corcept 正在發生的真正轉變。

It's now certain that there are many more patients with hypercortisolism than have been assumed in some sense all of its study. We weren't the first people to look at this, but the catalyst study definitively said that there just are many more patients who have the potential to be screened and then found and treated. And I really actually suggest to you that you read the paper in diabetes care. It's very accessible, plainly written, and will really describe in all the detail you need why the fact that hypercortisolism was underrepresented before is not going to be true for much longer.

現在可以肯定的是，患有皮質醇增多症的患者數量比某種意義上所有研究中假設的要多得多。我們並不是第一個研究這個問題的人，但催化劑研究明確表明，有更多的患者有可能接受篩檢，然後被發現和治療。我確實建議您閱讀有關糖尿病護理的論文。它非常容易理解，文筆清晰，並且會詳細地描述為什麼以前對皮質醇增多症的認識不足這一事實不會持續太久。

The second thing is that for many years the only molecule to approach glucocorticoid receptor antagonism, cortisol modulation in this way was Korlym mifepristone, and now we can unequivocally say that we have follow-on molecules which are more specific, starting with Relacorilant, more selective, have a much better side effect profile, and give us an opportunity to really look at more places where they can be useful clinically. And that really dovetails with the third point I want to make. ROSELLA unequivocally shows that cortisol modulation has utility outside of your basic Cushing's syndrome patients. It clearly worked in a very difficult group of patients with platinum resistant ovarian cancer. And I think it gives you good reason to think that it's going to work in a much wider range of cancers, both earlier in ovarian cancer and in other tumors where the glucocorticoid receptor is represented.

第二件事是，多年來，唯一能夠以這種方式實現糖皮質激素受體拮抗和皮質醇調節的分子是 Korlym 米非司酮，而現在我們可以毫不含糊地說，我們有了更具體的後續分子，從 Relacorilant 開始，它更具選擇性，具有更好的副作用特徵，並讓我們有機會真正研究它們在臨床上可以應用的更多地方。這與我要提出的第三點完全吻合。ROSELLA 明確表明皮質醇調節對庫欣氏症候群患者以外的人也有用。顯然，它對一組非常棘手的鉑耐藥性卵巢癌患者有效。我認為這給了你充分的理由相信它將在更廣泛的癌症中發揮作用，包括早期卵巢癌和其他存在糖皮質激素受體的腫瘤。

And so I really want you to start to think about Corcept as a company with a very broad medicinal platform.

因此，我真的希望您開始將 Corcept 視為一家擁有非常廣泛的醫療平台的公司。

Tumors, sorry, hormones go everywhere. And all of you are familiar with the broad amount of work which are being done with another hormone, GOP 1. My own opinion is that when the field is fully mined for the benefits of hypercortisolism, you will see that kind of reach and breath. So, thank you for all listening today, and I will see you next quarter.

腫瘤，對不起，荷爾蒙到處都是。大家都熟悉利用另一種荷爾蒙 GOP 1 進行的大量工作。我個人的觀點是，當該領域充分挖掘皮質醇增多症的益處時，你會看到那種影響力和呼吸。所以，感謝大家今天的收聽，我們下個季度再見。

Thank you. Bye.

謝謝。再見。

This concludes today's conference call.

今天的電話會議到此結束。

Thank you for participating. You may now disconnect.

感謝您的參與。您現在可以斷開連線。