Corcept Therapeutics Inc (CORT) 2023 Q3 法說會逐字稿

Good day, and welcome to the Corcept Therapeutics conference call. (Operator Instructions) Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Atabak Mokari, CFO. Please go ahead.

美好的一天，歡迎參加 Corcept Therapeutics 電話會議。 （操作員指示）請注意，今天的會議正在錄製中。現在我想將會議交給今天的發言人、財務長阿塔巴克·莫卡里 (Atabak Mokari)。請繼續。

Hello, everyone. Good afternoon, and thank you for joining. Today, we issued a press release announcing our financial results for the third 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. Today's call is being recorded. A replay will be available at the Investors/Events tab of our website.

大家好。下午好，感謝您的加入。今天，我們發布新聞稿，宣布第三季的財務業績並提供公司最新情況。副本可以在 corcept.com 上取得。當我們向 SEC 提交 10-Q 表格時，即可獲得完整的財務結果。今天的通話正在錄音。我們網站的投資者/活動選項卡上將提供重播。

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 differ materially from those such statements expressed or implied. These forward-looking statements are described in today's press release and the risks and uncertainties that may affect them are described in the press release and in our annual report and Form 10-K or our quarterly reports on Form 10-Q.

除歷史事實陳述外，本次電話會議期間的陳述均為基於我們的計劃和預期的前瞻性陳述，這些陳述存在風險和不確定性，可能導致實際結果與明示或暗示的此類陳述存在重大差異。這些前瞻性陳述在今天的新聞稿中進行了描述，可能影響這些前瞻性陳述的風險和不確定性在新聞稿以及我們的年度報告和表格10-K 或表格10-Q 的季度報告中進行了描述。

Please refer to those documents for additional information. We disclaim any intention or duty to update forward-looking statements. Our revenue in the third quarter of 2023 was $123.6 million, an increase of 22% compared to the third quarter of last year. We are raising our 2023 revenue guidance again to a range of $470 million to $480 million, up from $455 million to $470 million. Net income was $31.4 million or $0.28 per share in the third quarter. Our cash and investments at September 30 were $414.8 million, an increase of $51.5 million in the quarter. I will now turn the call over to Charlie Robb, our Chief Business Officer, to provide a legal update. Charlie?

請參閱這些文件以取得更多資訊。我們不承擔任何更新前瞻性陳述的意圖或義務。我們2023年第三季的營收為1.236億美元，比去年第三季成長22%。我們再次將 2023 年營收指引從 4.55 億美元至 4.7 億美元上調至 4.7 億美元至 4.8 億美元。第三季淨利為 3,140 萬美元，即每股 0.28 美元。截至 9 月 30 日，我們的現金和投資為 4.148 億美元，本季增加了 5,150 萬美元。我現在將把電話轉給我們的商務長查理羅伯 (Charlie Robb)，以提供最新的法律資訊。查理？

Thanks, Atabak. In March 2018, we sued Teva Pharmaceuticals to prevent it from marketing a generic version of Korlym in violation of our patents. This September 26 through 28, the case went to trial at Federal District Court in Camden, New Jersey. At trial, we asserted 2 patents against Teva, both of which concerned the co-administration of Korlym was a commonly prescribed class of medications known as strong CYP3A inhibitors. Teva does not and cannot dispute the validity of our patents. That matter was settled in our favor, but post grant review proceeding, Teva initiated and lost in 2019. Teva's only defense at trial was to argue that their generic product would not infringe either of our patents. This was the sole issue, infringement of either patents for the court.

謝謝，阿塔巴克。 2018 年 3 月，我們起訴 Teva Pharmaceuticals，阻止其銷售侵犯我們專利的 Korlym 仿製藥。今年9月26日至28日，此案在新澤西州卡姆登聯邦地方法院審理。在審判中，我們對 Teva 主張了 2 項專利，這兩項專利都涉及 Korlym 的共同給藥，Korlym 是一類常用的處方藥物，被稱為強效 CYP3A 抑制劑。 Teva 不會也不能質疑我們專利的有效性。該案以對我們有利的方式得到解決，但梯瓦(Teva) 發起了授權後審查程序，但在2019 年敗訴。梯瓦(Teva) 在審判中的唯一辯護是辯稱他們的仿製藥產品不會侵犯我們的任何一項專利。這是唯一的問題，即侵犯了法院的任何一項專利。

With trial over, here is what will happen next. As is customary, each party has submitted a post-trial brief arguing that it should win given the applicable law and the facts we've used in trial. In about a week, we will each submit a short reply brief responding to the arguments and the primary briefs. These documents are publicly available at the government's Pacer website, that's Pacer, P-A-C-E-R.

審判結束後，接下來會發生什麼。按照慣例，各方都提交了一份審後摘要，認為鑑於適用的法律和我們在審判中使用的事實，它應該勝訴。大約一週後，我們將各自提交一份簡短的答覆摘要，以回應論點和主要摘要。這些文件可在政府的 Pacer 網站上公開獲取，即 Pacer，P-A-C-E-R。

Once briefing is complete, the judge may or may not ask for oral argument. The verdict will follow most likely in the first quarter of next year. Of course, the timing is entirely for discretion. The losing party is entitled to appeal any adverse decision to the Federal Circuit Court of Appeals. Such an appeal will likely take between 12 and 18 months to complete. All in all, this dispute will likely not be completely resolved until the second or third quarter of 2025.

簡報完成後，法官可能會也可能不會要求進行口頭辯論。判決很可能會在明年第一季做出。當然，時間安排完全由我們自行決定。敗訴方有權就任何不利判決向聯邦巡迴上訴法院提出上訴。此類上訴可能需要 12 至 18 個月才能完成。總而言之，這場爭端很可能要到 2025 年第二季或第三季才能徹底解決。

Those of you who have joined our prior calls have heard me say in increasingly emphatic terms that we are confident in our case. I will say it again, we are confident in the strength of our case, supremely confident. We walked into court certain that the law and the facts are on our side. We left even more certain that the law and the facts are on our side. We look forward to the judge's verdict.

那些參加過我們之前電話會議的人已經聽到我越來越強調地說，我們對我們的案子充滿信心。我再說一遍，我們對我們案件的實力充滿信心，非常有信心。我們走進法庭，確信法律和事實都站在我們這邊。我們更確信法律和事實是站在我們這邊的。我們期待法官的判決。

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

我現在將把電話轉給我們的執行長喬貝拉諾夫 (Joe Belanoff)。喬？

Thank you, Charlie. Our strong results in the third quarter reflect physicians' increasing awareness of hypercortisolism and the harm it causes. As screening of the disease becomes more common, more physicians prescribe and more patients receive Korlym. This changing behavior has led to another record high in our quarterly revenue. We expect this trend in medical practice and, with it, our commercial growth to continue.

謝謝你，查理。我們第三季的強勁業績反映出醫生對皮質醇增多症及其造成的危害的認識不斷提高。隨著疾病篩檢變得越來越普遍，越來越多的醫生開出處方，越來越多的患者接受 Korlym 治療。這種變化的行為導致我們的季度收入再創歷史新高。我們預計醫療實踐中的這一趨勢以及隨之而來的我們的商業成長將持續下去。

Korlym is an excellent treatment for patients with Cushing's syndrome and there are many eligible patients who have yet to receive it. Leading endocrinologists increasingly believe that there are considerably more patients with Cushing's syndrome than was once assumed. The results of our CATALYST study will likely provide further evidence to bolster this belief, which will in turn lead physicians to identify and provide effective treatment for the large group of patients whose hypercortisolism currently goes undiagnosed. This advance in medical thinking will buoy our Cushing's syndrome business.

Korlym 對於庫欣氏症候群患者來說是一種極好的治療方法，並且有許多符合條件的患者尚未接受該治療。領先的內分泌學家越來越相信庫欣氏症候群患者的數量比以前想像的要多得多。我們的 CATALYST 研究結果可能會提供進一步的證據來支持這一信念，從而引導醫生識別目前尚未確診的大量皮質醇增多症患者並為其提供有效的治療。醫學思想的進步將提振我們的庫欣氏症候群業務。

We are raising our 2023 revenue range again this time to $470 million to $480 million. We're also very excited by the potential of our clinical development programs. Since inception, our research and development efforts have built on the hypothesis that cortisol modulation is a powerful therapeutic mechanism in many serious disorders. Our proprietary compounds modulate cortisol specs by binding to the glucocorticoid receptor or GR, the receptor which is activated when cortisol levels are high. They do not bind to the progesterone receptor and don't cause some of Korlym's, our approved product, most serious off-target effects.

這次我們再次將 2023 年的營收範圍提高至 4.7 億至 4.8 億美元。我們也對我們的臨床開發項目的潛力感到非常興奮。自成立以來，我們的研究和開發工作就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。我們的專有化合物透過與糖皮質激素受體或 GR 結合來調節皮質醇規格，該受體在皮質醇水平較高時會被活化。它們不與黃體酮受體結合，也不會引起我們批准的產品 Korlym 的一些最嚴重的脫靶效應。

Interestingly, while all our compounds modulate cortisol activity, they produce distinct clinical effects. Some cross the blood-brain barrier, others do not. Some perform best in models of solid tumors. Others are more potent in models of metabolic disease. Some appear to be tissue specific, others have more global events.

有趣的是，雖然我們所有的化合物都能調節皮質醇活性，但它們會產生不同的臨床效果。有些可以穿過血腦屏障，有些則不能。有些在實體腫瘤模型中表現最好。其他的在代謝疾病模型中較有效。有些似乎是組織特異性的，有些則有更多的全球事件。

These diverse qualities allow us to study a wide variety of disorders. Currently, we are conducting programs with 3 of our proprietary selective cortisol modulators, relacorilant, dazucorilant, and miricorilant, in ovarian, adrenal and prostate cancer, ALS, NASH and, of course, Cushing's syndrome.

這些不同的特性使我們能夠研究各種各樣的疾病。目前，我們正在使用 3 種專有的選擇性皮質醇調節劑（relacorilant、dazucorilant 和 miricorilant）開展項目，用於治療卵巢癌、腎上腺癌和前列腺癌、ALS、NASH，當然還有庫欣氏症候群。

Additional compounds are in earlier stages of development. Important late-stage clinical development milestones are approaching. In 2024, we expect data from our GRACE, GRADIENT, CATALYST, ROSELLA and DAZALS study. We also plan to submit an NDA for relacorilant in Cushing's syndrome and to complete enrollment of our Phase IIb MONARCH study in patients with NASH.

其他化合物正處於開發的早期階段。重要的後期臨床開發里程碑即將到來。 2024 年，我們預計將獲得 GRACE、GRADIENT、CATALYST、ROSELLA 和 DAZALS 研究的數據。我們也計劃提交庫欣氏症候群緩解劑的 NDA，並完成針對 NASH 患者的 IIb 期 MONARCH 研究的入組。

This is a very exciting time for Corcept. We are evaluating relacorilant for the treatment of hypercortisolism in 2 Phase III trials, GRACE and GRADIENT. Relacorilant is a selective cortisol modulator. Like Korlym, it achieves its effect by competing with cortisol as a glucocorticoid receptor.

對於 Corcept 來說，這是一個非常令人興奮的時刻。我們正在 GRACE 和 GRADIENT 兩項 III 期試驗中評估 relacorilant 治療皮質醇增多症的效果。 Relacorilant 是一種選擇性皮質醇調節劑。與 Korlym 一樣，它透過與皮質醇競爭作為糖皮質激素受體來實現其效果。

Unlike Korlym, it does not bind to the progesterone receptor and so does not cause progesterone-related side effects. Relacorilant's Phase II efficacy and safety data were compelling. Patients experienced meaningful improvements in hypertension, glucose control, as well as in the other signs and symptoms of Cushing's syndrome.

與 Korlym 不同，它不與孕酮受體結合，因此不會引起與黃體素相關的副作用。 Relacorilant 的 II 期療效和安全性數據令人信服。患者的高血壓、血糖控制以及庫欣氏症候群的其他徵兆和症狀均得到了有意義的改善。

There were no relacorilant-induced instances of endometrial thickening or vaginal bleeding, progesterone-related side effects, and no drug-induced hypokalemia, a leading cause of relacorilant continuation. The Phase II trial results were published in the journal, Frontiers in Endocrinology, in July 2021.

沒有因重新服藥引起的子宮內膜增厚或陰道出血、黃體酮相關副作用，也沒有藥物引起的低血鉀症（這是繼續服用重新服藥的主要原因）。 II 期試驗結果於 2021 年 7 月發表在《內分泌學前沿》雜誌。

We are focused on finishing our GRACE trial and preparing our NDA, which we plan to submit in the second quarter of 2024. Relacorilant has tremendous promise as a treatment for patients with all etiologies of endogenous Cushing's syndrome, and we are eager to make it available. Our second Phase III trial in hypercortisolism, GRADIENT, is studying relacorilant effects in patients whose Cushing's syndrome is caused by an adrenal adenoma or adrenal hyperplasia.

我們的重點是完成 GRACE 試驗並準備 NDA，我們計劃在 2024 年第二季度提交。Relacorilant 作為治療所有內源性庫欣綜合徵病因的患者俱有巨大的前景，我們渴望將其投入使用。我們的第二項皮質醇增多症 III 期試驗 GRADIENT 正在研究由腎上腺腺瘤或腎上腺增生引起的庫欣氏症候群患者的相關效應。

Patients with this etiology of Cushing's syndrome often experience a less rapid decline, but their health outcomes are poor, including a significantly higher risk to premature death. While we do not expect our NDA in Cushing's syndrome to depend on data from GRADIENT, we do expect the study to produce valuable data about the treatment of the etiology of Cushing's syndrome that affects many patients.

患有這種庫欣氏症候群病因的患者通常病情下降速度較慢，但他們的健康結果很差，包括過早死亡的風險顯著較高。雖然我們預期庫欣氏症候群的 NDA 不會依賴 GRADIENT 的數據，但我們確實期望該研究能夠產生有關影響許多患者的庫欣氏症候群病因治療的有價值的數據。

Our Phase IV CATALYST trial is the largest study ever conducted to establish the prevalence of hypercortisolism in patients with difficult to control diabetes. Many independent studies conducted over the last 15 years have found that the prevalence of hypercortisolism in patients with type 2 diabetes is substantially higher than in the general population.

我們的 IV 期 CATALYST 試驗是迄今為止規模最大的研究，旨在確定難以控制的糖尿病患者皮質醇增多症的盛行率。過去 15 年進行的許多獨立研究發現，2 型糖尿病患者皮質醇增多症的盛行率明顯高於一般人。

The most prominent diabetologists in the United States helped us design and are participating in CATALYST, which has the potential to become a landmark in guiding physicians' understanding of Cushing’s syndrome. We expect data from the prevalence phase of the CATALYST study early next year.

美國最著名的糖尿病專家幫助我們設計並參與了 CATALYST，該計畫有可能成為指導醫生了解庫欣氏症候群的里程碑。我們預計明年初 CATALYST 研究流行階段的數據。

Our oncology program is testing 3 anticancer mechanisms, first postulated by investigators at the University of Chicago and later confirmed by other prominent researchers. One mechanism is increasing apoptosis, the programmed cell death in chemotherapies meant to induce in solid tumors. Cortisol works against the beneficial effect of chemotherapy by suppressing apoptosis. In our successful controlled Phase II trial in women with platinum-resistant ovarian cancer, the addition of our selective cortisol modulator, relacorilant, enhanced the effect of chemotherapy, likely by blunting cortisol's anti-apoptotic effect.

我們的腫瘤學計畫正在測試 3 種抗癌機制，首先由芝加哥大學的研究人員提出，後來得到其他著名研究人員的證實。一種機制是增加細胞凋亡，即化療中旨在誘導實體腫瘤的程序性細胞死亡。皮質醇透過抑制細胞凋亡來對抗化療的有益作用。在我們對患有鉑耐藥性卵巢癌的女性進行的成功的對照 II 期試驗中，添加我們的選擇性皮質醇調節劑 relacorilant 可能透過削弱皮質醇的抗細胞凋亡作用來增強化療的效果。

Relacorilant provided meaningful benefit to many of the women in our study. While these women's disease had progressed on two or more previous lines of treatment, including previous taxanes, relacorilant appeared to resensitize their tumors to chemotherapy's beneficial effects. Those who received relacorilant intermittently, the day before, the day of and the day after they received nab-paclitaxel, exhibited a statistically significant improvement in progression-free survival and duration of response compared to the group who received nab-paclitaxel monotherapy.

Relacorilant 為我們研究中的許多女性帶來了有意義的益處。雖然這些女性的疾病在先前的兩種或多種治療方案（包括先前的紫杉烷類藥物）中有所進展，但 relacorilant 似乎使她們的腫瘤對化療的有益效果重新敏感。與接受白蛋白結合型紫杉醇單一療法的組別相比，那些在接受白蛋白結合型紫杉醇治療前一天、當天和後一天間歇性接受relacorilant 治療的患者，在無進展生存期和反應持續時間方面表現出統計上顯著的改善。

Women in the intermittent relacorilant group also lived longer than those of the comparator arm with a p-value that approached statistical significance. 29% of the patients who took intermittent relacorilant were alive 2 years after study start versus only 14% of those who took nab-paclitaxel alone. Just as important, women who received relacorilant plus nab-paclitaxel experienced no additional side effect burden compared to those who received nab-paclitaxel alone.

間歇性抵抗組的女性也比對照組的女性壽命更長，p 值接近統計顯著性。間歇性服用 relacorilant 的患者中有 29% 在研究開始後 2 年後仍存活，而單獨服用白蛋白結合型紫杉醇的患者中只有 14% 存活。同樣重要的是，與單獨接受白蛋白結合型紫杉醇治療的女性相比，接受 relacorilant 加白蛋白結合型紫杉醇治療的女性沒有經歷額外的副作用負擔。

The results from this study were published in the Journal of Clinical Oncology in June of this year. Results (technical difficulty) have also been featured in podium presentations at the 2021 and 2022 European Society for Medical Oncology, ESMO, meetings and at the 2022 American Society of Clinical Oncology, ASCO Annual Meeting.

這項研究的結果發表在今年六月的《臨床腫瘤學雜誌》。結果（技術難度）也出現在 2021 年和 2022 年歐洲腫瘤內科學會 (ESMO) 會議以及 2022 年美國臨床腫瘤學會 (ASCO) 年會上的講台演講中。

ROSELLA, our pivotal multinational Phase III trial in platinum-resistant ovarian cancer is enrolling patients. ROSELLA's goal is simply to replicate our positive Phase II results in a larger group. ROSELLA's design closely tracks our Phase II study. Planned enrollment is 360 women randomized 1:1 to receive either relacorilant plus nab-paclitaxel or nab-paclitaxel alone.

ROSELLA 是我們針對鉑類抗藥性卵巢癌的關鍵跨國 III 期試驗，正在招募病患。 ROSELLA 的目標只是在更大的群體中複製我們第二階段的正面結果。 ROSELLA 的設計密切追蹤我們的 II 期研究。計畫招募 360 名女性，以 1:1 的比例隨機分配接受 relacorilant 加白蛋白結合型紫杉醇或單獨接受白蛋白結合型紫杉醇治療。

The primary endpoint is progression-free survival with overall survival a key secondary endpoint. We are conducting this study in collaboration with leading clinicians from the Gynecological Oncology Group in the United States and the European Network of Gynecological Oncology Trials Group in Europe.

主要終點是無惡化存活期，總存活期是關鍵的次要終點。我們正在與美國婦科腫瘤學組和歐洲婦科腫瘤試驗組歐洲網路的領先臨床醫生合作進行這項研究。

We expect data by the end of next year. Leading gynecological oncologists have told us that relacorilant's potential benefit, improved progression-free and overall survival without increased side effect burden, would constitute an important medical advance, and the relacorilant plus nab-paclitaxel has the potential to become a new standard of care in women with platinum-resistant ovarian cancer.

我們預計明年年底會有數據。領先的婦科腫瘤學家告訴我們，relacorilant 的潛在益處，即在不增加副作用負擔的情況下改善無進展生存期和總體生存率，將構成一項重要的醫學進步，並且relacorilant 聯合白蛋白結合型紫杉醇有可能成為女性新的護理標準患有鉑耐藥性卵巢癌。

A second mechanism by which cortisol modulation may prove useful is by blocking an important tumor growth pathway. Cortisol stimulation is a major reason why patients with prostate cancer treated with a widely prescribed androgen receptor antagonist, enzalutamide, eventually experience resurgent disease. Deprived of androgen stimulation, the tumors switch the cortisol activity to stimulate gland. Our hypothesis is that adding a cortisol modulator to androgen deprivation therapy will close this tumor escape route.

皮質醇調節可能被證明有用的第二種機制是阻斷重要的腫瘤生長路徑。皮質醇刺激是前列腺癌患者接受廣泛使用的雄性激素受體拮抗劑恩雜魯胺治療後最終病情復發的主要原因。失去雄性激素刺激後，腫瘤會切換皮質醇活性以刺激腺體。我們的假設是，在雄性激素剝奪療法中添加皮質醇調節劑將關閉腫瘤的逃脫途徑。

Our collaborators at the University of Chicago have initiated a randomized placebo-controlled Phase II trial of relacorilant plus enzalutamide in patients with prostate cancer before these patients have had an initial prostatectomy.

我們在芝加哥大學的合作者在前列腺癌患者進行初次前列腺切除術之前啟動了一項隨機安慰劑對照 II 期試驗，該試驗使用 relacorilant 加恩雜魯胺。

A third therapeutic mechanism seeks to treat tumors by enhancing the body's immune response. Cortisol suppresses the immune system, which may blunt the effectiveness of cancer therapies intended to stimulate the immune system. Our hypothesis is that adding a cortisol modulator to immunotherapies such as checkpoint inhibitors may enhance the effectiveness of those therapies. We are conducting a Phase Ib trial of relacorilant plus the PD-1 checkpoint inhibitor, pembrolizumab, in patients with advanced adrenal cancer, whose tumors produce excess cortisol. Pembrolizumab is rarely effective as monotherapy in treating this form of adrenal cancer.

第三種治療機制旨在透過增強人體的免疫反應來治療腫瘤。皮質醇會抑制免疫系統，這可能會削弱旨在刺激免疫系統的癌症療法的有效性。我們的假設是，在免疫療法（例如檢查點抑制劑）中添加皮質醇調節劑可能會增強這些療法的有效性。我們正在對晚期腎上腺腺癌患者進行 relacorilant 合併 PD-1 檢查點抑制劑 pembrolizumab 的 Ib 期試驗，這些患者的腫瘤會產生過量的皮質醇。派姆單抗作為單一療法治療這種形式的腎上腺腺癌很少有效。

ALS, commonly known as Lou Gehrig's disease is a devastating illness with an urgent need for better treatment. DAZALS, our 198-patient randomized double-blind placebo-controlled Phase II trial of dazucorilant in patients with ALS is enrolling patients briskly. Dazucorilant is a selective cortisol modulator that has shown great promise in animal models of ALS, improving motor performance and reducing neural inflammation and muscular atrophy. We are conducting this important study at sites in Europe and the United States. We expect data by the end of next year.

ALS，俗稱盧伽雷氏症，是一種毀滅性的疾病，迫切需要更好的治療。 DAZALS 是我們針對 ALS 患者所進行的 dazucorilant II 期隨機雙盲安慰劑對照試驗，目前正快速招募患者。 Dazucorilant 是一種選擇性皮質醇調節劑，在 ALS 動物模型中顯示出巨大的前景，可改善運動表現並減少神經發炎和肌肉萎縮。我們正在歐洲和美國進行這項重要的研究。我們預計明年年底會有數據。

Finally, I'll turn to our program in NASH, a serious liver disorder that afflicts millions of patients in the United States. Miricorilant, an oral medication, continues to demonstrate great promise as a treatment for NASH. In our prior NASH study, patients who received 600 milligrams or 900 milligrams of miricorilant daily exhibited large rapid reductions in liver fat, but also substantial, albeit transient, elevations of liver enzymes, ALT and AST.

最後，我將談談我們在 NASH 方面的項目，NASH 是一種嚴重的肝臟疾病，困擾著美國數百萬名患者。 Miricorilant 是一種口服藥物，在治療 NASH 方面繼續展現出巨大的前景。在我們先前的NASH 研究中，每天接受600 毫克或900 毫克miricorilant 的患者表現出肝臟脂肪大幅快速減少，但肝酶、谷丙轉氨酶(ALT) 和穀草轉氨酶(AST) 也顯著升高，儘管是短暫的。

The improvement in liver fat in these patients was greater and occurred much more rapidly than we had expected and is rarely seen over any period of treatment. Our Phase Ib dose-finding study found that patients who received just 100 milligrams of miricorilant orally twice a week for 12 weeks experienced an approximately 30% reduction in liver fat and showed improvements in liver enzymes and markers of liver disease.

這些患者的肝臟脂肪改善程度比我們預期的要大得多且發生得快得多，並且在任何治療期間都很少見。我們的 Ib 期劑量探索研究發現，每週兩次口服 100 毫克 miricorilant 持續 12 週的患者，肝臟脂肪減少了約 30%，肝酵素和肝病標記物也有所改善。

These patients also experienced improvements in key metabolic and lipid measures such as HOMA-IR, serum triglycerides and LDL. Importantly, miricorilant was very well tolerated with no apparent GI side effects. We will present these results at the upcoming AASLD meeting in Boston. We intend to build on the promising results of our Phase Ib study with our 150-patient randomized double-blind placebo-controlled Phase IIb MONARCH trial, miricorilant in patients with biopsy-confirmed NASH.

這些患者的關鍵代謝和血脂指標（例如 HOMA-IR、血清三酸甘油酯和低密度脂蛋白）也得到改善。重要的是，miricorilant 的耐受性非常好，沒有明顯的胃腸道副作用。我們將在即將於波士頓舉行的 AASLD 會議上展示這些結果。我們打算在 Ib 期研究的有希望的結果的基礎上，透過我們的 150 名患者隨機雙盲安慰劑對照 IIb 期 MONARCH 試驗，對活檢確診的 NASH 患者進行 miricorilant 試驗。

Patients will receive either 100 milligrams of miricorilant or placebo orally twice weekly for 48 weeks. The primary endpoint is reduction in liver fat, NASH resolution, and fibrosis improvement as key secondary endpoints.

患者將每週兩次口服 100 毫克 miricorilant 或安慰劑，持續 48 週。主要終點是肝臟脂肪減少、NASH 消退和纖維化改善作為關鍵的次要終點。

In conclusion, we are extremely optimistic about the future of Corcept. Our Cushing's syndrome business has tremendous growth potential and generate substantial profits even as we invest in our advancing development programs. We are again raising our 2023 revenue guidance and anticipate growth for years to come.

總而言之，我們對 Corcept 的未來非常樂觀。我們的庫欣氏症候群業務具有巨大的成長潛力，即使我們投資於先進的開發項目，也能產生可觀的利潤。我們再次提高 2023 年收入指引，並預期未來幾年的成長。

Data from our large CATALYST study will help physicians better identify and treat patients whose difficult to control diabetes is caused by hypercortisolism, a population whose Cushing's syndrome too frequently goes undiagnosed. Our development programs are generating increasing evidence that cortisol modulation has the potential to treat a wide range of diseases.

我們大型 CATALYST 研究的數據將幫助醫生更好地識別和治療因皮質醇增多症而難以控製糖尿病的患者，而這些患者的庫欣氏症候群經常未被診斷出來。我們的開發計劃正在產生越來越多的證據，顯示皮質醇調節具有治療多種疾病的潛力。

Cushing's syndrome, ovarian cancer, prostate cancer, ALS, and NASH are current examples. There will be others. We have many more proprietary selective cortisol modulators in our portfolio with potentially very different clinical attributes. We will advance the most promising of these to the clinic. In 2024, we expect data from our GRACE, GRADIENT, and CATALYST studies in Cushing's syndrome, our pivotal ROSELLA trial in ovarian cancer, and our DAZALS study in ALS.

目前的例子包括庫欣氏症候群、卵巢癌、前列腺癌、ALS 和 NASH。還會有其他人。我們的產品組合中有更多專有的選擇性皮質醇調節劑，它們的臨床屬性可能非常不同。我們將把其中最有前景的藥物推進臨床。 2024 年，我們預期庫欣氏症候群的 GRACE、GRADIENT 和 CATALYST 研究、卵巢癌的關鍵 ROSELLA 試驗以及 ALS 的 DAZALS 研究將獲得數據。

We expect to submit an NDA for relacorilant in Cushing's syndrome and to complete enrollment in our MONARCH Phase IIb study in NASH. As I have said, it is an exciting time for Corcept. Before we take questions, I want to take a moment to introduce the newest member of our executive team, Monica Tellado, whose first day at Corcept is today. Monica, as President of Emerging Markets, will be responsible for our newer therapeutic areas such as ALS and NASH. We look forward to her contributions. Monica, welcome to Corcept. Let's proceed now to questions.

我們預計將提交庫欣氏症候群緩解劑的新藥申請 (NDA)，並完成 NASH 的 MONARCH IIb 期研究的入組。正如我所說，對於 Corcept 來說，這是一個令人興奮的時刻。在我們回答問題之前，我想花點時間介紹一下我們管理團隊的最新成員 Monica Tellado，今天是她在 Corcept 的第一天。 Monica 身為新興市場總裁，將負責 ALS 和 NASH 等較新的治療領域。我們期待她的貢獻。莫妮卡，歡迎來到科西普。現在讓我們繼續提問。

(Operator Instructions) Our first question comes from Matt Kaplan with Ladenburg.

（操作員說明）我們的第一個問題來自拉登堡的馬特卡普蘭。

Congrats on a strong quarter. To delve into your pipeline a little bit and specifically your near-term readouts that you have coming up in 2024. I guess specifically, first, can you talk a little bit more about the GRACE study and the primary endpoint there and what you're looking to show with the GRACE study.

恭喜季度表現強勁。為了深入研究你的管道，特別是你在 2024 年提出的近期讀數。我想具體來說，首先，你能多談談 GRACE 研究和主要終點以及你的目標嗎？希望透過 GRACE 研究來展示。

Hey, Matt, I apologize. I'm really having trouble hearing your question. The line isn't so good. Is it possible to either repeat it or call back in?

嘿，馬特，我道歉。我真的很難聽清楚你的問題。線路不太好。是否可以重複或回電？

A different way? Is that any better?

另一種方式？這樣好點了嗎？

No, we're just not hearing you. I'm sorry, Matt. Why don't you re-dial. We'll take that again.

不，我們只是沒有聽到你的聲音。對不起，馬特。為什麼不重新撥號呢？我們會再次採取這一點。

Our next question comes from David Amsellem with Piper Sandler.

我們的下一個問題來自 David Amsellem 和 Piper Sandler。

I hope you can hear me well. So a couple of questions. First, can you provide specifics on the year-over-year volume growth for Korlym? That's number one. And then I guess as part of that question, my understanding is third quarter last year was somewhat weaker. So potentially, we're looking at more favorable year-over-year comps. So just talk about the volume growth dynamics. I know there was also pricing action earlier this year. So just help us understand what was volume, what was price? And then in terms of your comments on screening for hypercortisolism and greater diagnoses and treatment starts. What does that mean going forward? I know you're not in a position to guide for '24, but is what we're seeing, this seeming inflection, is that something that you're looking at as sustainable?

我希望你能好好聽我說話。有幾個問題。首先，您能否提供有關 Korlym 同比銷量成長的具體資訊？這是第一名。然後我想作為這個問題的一部分，我的理解是去年第三季的情況有些疲軟。因此，我們可能會尋找更有利的同比比較。所以只談談銷量成長動態。我知道今年早些時候也有定價行動。那麼請幫助我們了解什麼是數量，什麼是價格？然後就您對皮質醇增多症篩檢以及更好的診斷和治療開始的評論而言。這意味著什麼？我知道你無法為 24 世紀的發展提供指導，但我們所看到的這種看似變化的情況，你認為是可持續的嗎？

Okay. Thank you, David. I think we've got both of those questions. I personally want to introduce to everyone -- reintroduce to everyone, Sean Maduck, who is the President of our Endocrinology Division. And he can address your first question.

好的。謝謝你，大衛。我想我們已經有這兩個問題了。我個人想向大家介紹──重新向大家介紹肖恩‧馬杜克（Sean Maduck），他是我們內分泌科的主任。他可以回答你的第一個問題。

David, thank you for the question. So in terms of year-on-year growth, we had 22% growth, 12% of that was driven by volume and 9% was driven by price. And I think your next question was sort of the sustainability through Q4. I mean that's built into our range. We expected the growth we experienced in Q3, and we expect that growth to continue for many quarters. We had more new physicians and existing physicians prescribe Korlym for patients across the country, and that's what drove our increased guidance range and the revenue that you see.

大衛，謝謝你的提問。因此，就同比增長而言，我們增長了 22%，其中 12% 是由數量驅動的，9% 是由價格驅動的。我認為你的下一個問題是第四季的可持續性。我的意思是，這已納入我們的產品範圍內。我們預計第三季會出現成長，並且預計這種成長將持續多個季度。我們有更多的新醫生和現有醫生為全國各地的患者開立 Korlym 處方，這就是推動我們擴大指導範圍和您看到的收入的原因。

Yes. And David, as a general answer to your second question, I think what we're really seeing out in the world is the recognition that hypercortisolism is considerably more common than I think people once assumed. While it's not -- there are not 1 million people with hypercortisolism, it's not the ultra-rare disease that people once thought it was.

是的。大衛，作為對你的第二個問題的一般性回答，我認為我們在世界上真正看到的是認識到皮質醇增多症比我認為人們曾經想像的要普遍得多。雖然事實並非如此——患有皮質醇增多症的人還不到 100 萬人，但它並不是人們曾經認為的那種極為罕見的疾病。

So we actually think that this expansion because of really screening is going to continue for a substantial period of time. Some of those patients will eventually fall to Korlym. Others will be treated in different ways. But the idea that this is an important medical therapeutic area that has really been under-addressed, I think, is seeing acceleration.

因此，我們實際上認為，由於真正的篩選而導致的這種擴張將持續相當長的一段時間。其中一些患者最終會落入科林。其他人將受到不同的對待。但我認為，這是一個重要的醫學治療領域，但實際上一直沒有被充分重視，而這個想法正在加速發展。

That's helpful. If I may sneak in a quick follow-up. In terms of the new starts and just the growth, are you getting a good chunk of that growth from physicians who are new to Korlym treatment?

這很有幫助。我可以快速跟進嗎？就新的開始和成長而言，您是否從剛接觸 Korlym 治療的醫生那裡獲得了很大一部分增長？

I'm going to pass you back to Sean.

我會把你轉回給肖恩。

Yes. Thank you for the questions. We're getting a mix of both, the new prescribers every single month -- every single quarter, and we also have physicians that have previously prescribed Korlym prescribe again for many subsequent patients potentially. So the short answer is yes, across both groups.

是的。謝謝你的提問。我們每個月、每季都會得到兩者的混合，新的處方者，我們也有以前開過 Korlym 處方的醫生可能會再次為許多後續患者開處方。所以簡短的答案是肯定的，對於兩組來說都是如此。

Our next question comes from Matt Kaplan with Ladenburg.

我們的下一個問題來自拉登堡的馬特卡普蘭。

Can you hear me now?

你聽得到我嗎？

Much better. Thank you, Matt.

好多了。謝謝你，馬特。

Great. Great. Great. Yes. So first off, congrats on a very strong quarter. I just wanted to focus a little bit on your pipeline. Obviously, 2024 is going to be a significant year for you guys with a lot of data readouts. And just in terms of the near-term readouts, can you give us a little bit more color on the GRACE study and what you're looking to show there, primary endpoint and, I guess, results should be potentially available in the first quarter given your desire to file an NDA in the second quarter.

偉大的。偉大的。偉大的。是的。首先，恭喜一個非常強勁的季度。我只是想稍微關心一下你的管道。顯然，2024 年對你們來說將是重要的一年，會有大量的數據讀出。就近期數據而言，您能否為我們提供有關 GRACE 研究的更多資訊以及您希望在其中展示的內容、主要終點以及我認為結果可能會在第一季度公佈鑑於您希望在第二季度提交NDA 。

Thanks, Matt. We've heard all of that. I want to reintroduce the group to Bill Guyer. Bill runs all of our development programs. He can answer your specific question.

謝謝，馬特。這些我們都聽過。我想把這個團體重新介紹給比爾蓋耶。比爾負責我們所有的開發案。他可以回答你的具體問題。

Great. Thanks, Matt. So let me remind you, the GRACE trial is an ongoing study with 2 parts in it. It's basically 2 studies in 1. The first part is the open label part of the study, where we're evaluating escalation of dosing from 100 milligrams up to the maximum dose of 400 milligrams. And for those who meet response criteria for diabetes and/or hypertension both, then get into the randomized withdrawal study, which is our primary endpoint of that study.

偉大的。謝謝，馬特。因此，讓我提醒您，GRACE 試驗是一項正在進行的研究，分為兩個部分。這基本上是 2 項研究合 1 項研究。第一部分是研究的開放標籤部分，我們正在評估從 100 毫克到最大劑量 400 毫克的劑量遞增。對於同時滿足糖尿病和/或高血壓緩解標準的人，則進入隨機退出研究，這是我們研究的主要終點。

We're going to share, as you put it, top line results and overall results when there is material information within the first half of the year as we progress towards our NDA. When you think of a success, the success for this program would be treating patients with Cushing's syndrome and seeing their Cushing's syndrome improve dramatically.

正如您所說，隨著我們在 NDA 方面取得進展，當上半年出現重大資訊時，我們將分享頂線結果和整體結果。當你想到成功時，這個計畫的成功就是治療庫欣氏症候群患者並看到他們的庫欣氏症候群得到顯著改善。

I mean, we're really treating very sick patients with Cushing's syndrome in the GRACE trial. And relacorilant is a key in that treatment because it modifies the underlying disease of Cushing's syndrome. Success, when you look at the primary endpoint, would be to evaluate those patients who respond to relacorilant. And when they go into the randomized withdrawal part, they get switched to either staying on relacorilant or switching to placebo. And so we're evaluating the maintenance of their response, hypertension and/or diabetes control, or losing that response, and that's what we're going to be evaluating.

我的意思是，在 GRACE 試驗中，我們確實正在治療病情嚴重的庫欣氏症候群患者。緩和劑是此治療的關鍵，因為它可以改變庫欣氏症候群的潛在疾病。當您查看主要終點時，成功將是評估那些對 relacorilant 有反應的患者。當他們進入隨機戒斷部分時，他們要么繼續服用緩和劑，要么改用安慰劑。因此，我們正在評估他們的反應、高血壓和/或糖尿病控制的維持情況，或失去這種反應，這就是我們將要評估的內容。

Okay. That's very helpful. And then if you could, a little bit more color in terms of the data that you're expecting from the first part of the study where you're taking a look at the CATALYST in terms of the prevalence. What should we be expecting as you announce the prevalence results in the first quarter?

好的。這非常有幫助。然後，如果可以的話，在研究第一部分中您所期望的數據上多一點色彩，您正在研究催化劑的流行率。當您公佈第一季的盛行率結果時，我們應該期待什麼？

Sure. Thank you for that second question. The goal for the CATALYST trial is pretty simple. It's to replicate and confirm the research from the past 15 years from publications of cohort studies showing the patients with difficult to control diabetes will have a positive dexamethasone suppression test, what we call a DST, with a prevalence in the range of approximately 10% to 20%. And so right now, we're well within that range for the CATALYST study. We look to complete that study by the end of this quarter and publicize that within the first quarter of next year.

當然。謝謝你的第二個問題。 CATALYST 試驗的目標非常簡單。這是為了複製和證實過去15 年發表的隊列研究中的研究，這些研究顯示難以控制的糖尿病患者會進行陽性地塞米松抑制試驗，即我們所說的DST，其患病率約為10% 至10%。 20%。所以現在，我們完全處於 CATALYST 研究的範圍之內。我們希望在本季末完成這項研究，並在明年第一季內公佈。

Our next question comes from Roanna Ruiz with Leerink.

我們的下一個問題來自 Leerink 的 Roanna Ruiz。

So first question. Curious if you could update us about your -- remind us about your IP expectations for Korlym and relacorilant in endogenous Cushing's. I was just curious if there are any implications that we should think about with the recent developments with your litigation with Teva there?

所以第一個問題。很好奇您能否向我們介紹您的最新情況——提醒我們您對 Korlym 和內源性庫欣的 relacorilant 的 IP 期望。我只是好奇您與 Teva 訴訟的最新進展是否有任何我們應該考慮的影響？

Yes, I'm going to pass you back to Charlie Robb, who really is responsible for all of our legal issues.

是的，我將把您轉回查理羅伯（Charlie Robb），他真正負責我們所有的法律問題。

Yes. I guess I'll sort of take it into 2 parts, obviously, because our IP protections for Korlym and for relacorilant are really completely separate. As far as the developments go with respect to Korlym, as I mentioned, we had the trial at the end of September. And I really want to stress that there, the patents we are defending, we are asserting against Teva, really concern the co-administration of Korlym with a really broadly prescribed class of drugs that are important drugs for everyone, but also are commonly prescribed in patients with Cushing's syndrome. So the trial, I think, went very well. I think we've made exactly the case we needed to make. And so in terms of commentary on our Korlym IP, I feel very good about it. I think we'll win. We brought it out into court, it performed very well, and I'm confident that it's now in the hands of the judge. That IP runs through 2037. So those 2 patents, and there will or maybe further patents that come out of our work in the coming months and years with respect to Korlym. But right now, we're protected through 2037.

是的。顯然，我想我會把它分成兩部分，因為我們對 Korlym 和 relacorilant 的智慧財產權保護實際上是完全分開的。就 Korlym 的進展而言，正如我所提到的，我們在 9 月底進行了審判。我真的想強調，我們正在捍衛的專利，我們對Teva 主張的專利，確實涉及Korlym 與一類真正廣泛處方的藥物的共同給藥，這些藥物對每個人來說都是重要的藥物，但也通常在庫欣氏症候群患者。所以我認為審判進行得很順利。我認為我們已經提出了我們需要提出的情況。所以就我們 Korlym IP 的評論而言，我感覺非常好。我想我們會贏。我們把它帶到法庭上，它表現得非常好，我相信它現在已經到了法官的手中。該智慧財產權將持續到 2037 年。因此，這兩項專利，以及在未來幾個月和幾年中我們的工作中將會或可能會出現更多與 Korlym 相關的專利。但現在，我們的保護期一直持續到 2037 年。

Now relacorilant is a novel proprietary compound, unlike Korlym, which is the active ingredient, is a generic compound. And so with respect to relacorilant, we have patents on its composition of matter. We have patents for a variety of uses for the compound and for its sister compounds in a range of disorders, including the ones that we're studying now. And that protection runs past '24. So we have, I think, extremely robust sort of multilayered sort of IP surrounding relacorilant and there will be more being developed as our investigations continue to make new inventions that are worthy of that protection. So I hope that answered your question.

現在 relacorilant 是一種新型專有化合物，與活性成分 Korlym 不同，Korlym 是一種通用化合物。因此，對於 relacorilant，我們擁有其物質成分的專利。我們擁有該化合物及其姐妹化合物在一系列疾病中的多種用途的專利，包括我們現在正在研究的疾病。這種保護持續到 24 世紀之後。因此，我認為，我們擁有極其強大的圍繞 relacorilant 的多層智慧財產權，並且隨著我們的調查繼續創造值得保護的新發明，將會開發出更多智慧財產權。所以我希望這回答了你的問題。

Yes, that helps. And then a second one I had just tagging on about the GRACE trial reading out soon. I was just curious if you could explain what the statistical powering is for the endpoint there? And anything else we should think about in the data?

是的，這有幫助。然後我剛剛標記的第二個關於 GRACE 試驗的內容很快就會讀出。我只是好奇你能否解釋一下終點的統計功效是什麼？在數據中我們還應該考慮什麼？

Sure. I'll answer that question. So the statistical powering is to look at the loss of response. We have 90% power to protect a loss of response of about a 50% difference between staying on relacorilant and maintaining that response or switching to placebo and losing that response.

當然。我來回答這個問題。因此，統計功效是考察響應的損失。我們有 90% 的能力來保護反應喪失，而繼續使用緩和劑並維持反應或改用安慰劑並失去反應之間的差異約為 50%。

our next question comes from Joon Lee with Truist.

我們的下一個問題來自 Joon Lee 和 Truist。

Congrats on the strong quarter. I have a question on timing of the NDA submission in the second quarter of next year. Would you want to wait for the GRADIENT study by midyear to submit a more fuller picture of the drug? What's the rush there? And would the FDA want to see that? And the other question is, what are the drivers of Korlym franchise that keeps surprising you to the upside?

恭喜季度表現強勁。我對明年第二季 NDA 提交的時間有疑問。您是否想等到年中進行 GRADIENT 研究後才能提交更全面的藥物狀況？那裡有什麼急事？ FDA 願意看到這一點嗎？另一個問題是，Korlym 特許經營權的驅動因素是什麼，讓您不斷獲得驚喜？

Okay. 2 different questions. Let me, Joon, give you first to Charlie for the NDA question.

好的。 2個不同的問題。讓我，Joon，首先向 Charlie 提出 NDA 問題。

So yes, we think that the most important demonstrator of relacorilant's safety and efficacy in Cushing's syndrome will be the GRACE trial. We think that's sufficient to support our NDA. And so we're going to go with that, because it will be ready and ready first, ready to proceed, and just continue to move our business forward as expeditiously as possible. We will be in a position just procedurally to submitting additional data to the FDA as GRADIENT comes in, if that's important to pressing the NDA forward. So I think we retain some real optionality there without having to sacrifice the pace of our timelines.

所以，是的，我們認為 GRACE 試驗將是 relacorilant 在庫欣氏症候群中安全性和有效性的最重要證明。我們認為這足以支持我們的保密協議。因此，我們將繼續這樣做，因為它將首先做好準備，準備好繼續進行，並繼續盡可能迅速地推動我們的業務向前發展。當 GRADIENT 出現時，我們將能夠在程序上向 FDA 提交額外的數據，如果這對於推動 NDA 的進展很重要的話。因此，我認為我們保留了一些真正的選擇性，而不必犧牲我們的時間表的節奏。

And Joon, the second question, would you please repeat that?

Joon，第二個問題，請你再說一次好嗎？

Yes, yes. So what are the drivers of Korlym franchise that keep surprising you to the upside? You upgraded guidance I think 2 quarters in a row, if I'm not mistaken. So just curious what's the driver of that?

是的是的。那麼，Korlym 特許經營權的驅動因素是什麼，讓您不斷獲得驚喜呢？如果我沒記錯的話，我想你已經連續兩個季度升級了指引。所以只是好奇這的驅動因素是什麼？

Good. No, I understand the question, and I'm going to pass it back to Sean.

好的。不，我明白這個問題，我會把它轉回給肖恩。

Yes, Joon. Thank you for the question. I mean, these results have been expected given this is where we have been investing. And in the past, I've talked a little bit about some of the initiatives we've been investing in to grow our business. And I thought I'd take a minute to update everybody on where those are at now. Before I do that, though, I want to highlight, I think, an important fact. And that said, we have a very clear understanding, now more so than in the past, that this is a multi-billion dollar market opportunity and the investments that we have made to grow our business and we will continue to make are highly leveraged, and we expect that they will both capture the opportunity and then yield a higher rate of return.

是的，瓊。感謝你的提問。我的意思是，考慮到這是我們一直在投資的領域，這些結果是可以預期的。過去，我談過一些我們為發展業務而投資的一些舉措。我想我應該花一點時間向大家通報目前的最新情況。不過，在此之前，我想先強調一個重要的事實。也就是說，我們現在比過去有一個非常清晰的認識，這是一個數十億美元的市場機會，我們為發展業務而進行的投資以及我們將繼續進行的投資都是高槓桿的，我們預計他們都會抓住機會，然後產生更高的報酬率。

So from an initiative standpoint, which is what we're talking about, there's 3 that we previously discussed on calls, the first being the expansion of our sales force, the second is the increased effectiveness of our team. And then the third being the initiation of the CATALYST study, which Bill just spoke about.

因此，從我們正在討論的主動性角度來看，我們之前在電話中討論過三個問題，第一個是擴大我們的銷售隊伍，第二個是提高我們團隊的效率。第三個是比爾剛才談到的 CATALYST 研究的啟動。

Now in terms of the sales force and the size of that team, we're currently in the mid-60s, and we are continuing to add clinical specialists throughout the country. Our target right now is about 75, but we're unlikely to stop there, and we're going to continue to add top sales talent as we find them. And so part of the driver of the result is seeing that both our existing clinical specialists and some of our newer clinical specialists are starting to become more effective and produce more.

現在就銷售隊伍和團隊規模而言，我們目前處於 60 年代中期，我們正在繼續在全國範圍內增加臨床專家。我們目前的目標是 75 名左右，但我們不太可能就此止步，我們將繼續增加找到的頂尖銷售人才。因此，這項結果的部分驅動因素是我們現有的臨床專家和一些新的臨床專家開始變得更有效率並產生更多成果。

The second initiative really has been around that productivity driver. And what we've done is strengthen and streamline our training program with the goal to do what I just touched on, make our existing people more effective and make our newer hires more effective more quickly. And again, we're starting to see results from that effort.

第二項舉措其實是圍繞著生產力驅動因素展開的。我們所做的就是加強和簡化我們的培訓計劃，目標是完成我剛才提到的事情，使我們現有的員工更加高效，並使我們的新員工更快地更有效率。我們再次開始看到這項努力的成果。

So the last piece from an investment standpoint is CATALYST. Bill just talked through the historical studies in the 10% to 20% range. But what I want everyone listening to recognize is that CATALYST is going to be the largest prospective study ever done by this group. And I believe personally, and others do as well, that it will be the definitive study for this patient population that's really going to cement these findings from the studies that came before it.

所以從投資的角度來看，最後一塊就是CATALYST。 Bill剛剛講了10%到20%範圍內的歷史研究。但我希望每個聽的人都認識到，CATALYST 將成為該小組有史以來規模最大的前瞻性研究。我個人和其他人也相信，這將是針對該患者群體的權威研究，真正將鞏固先前研究的這些發現。

Now if we can replicate that 10% to 20% prevalence rate, it is going to be an extremely meaningful driver for our business. You have to recognize that there are still many physicians out there that think the prevalence in this patient population is near zero. So our growth today has been driven by slowly educating physicians to both screen and look for this disease. But we expect that with the addition of that data, we'll see that continue to evolve. So in summary, we have a lot of different initiatives in play, but we're at the very early stages of seeing the value from those. Many of them are just getting going, and we expect to see growth not just through the rest of this year but into 2024 and beyond.

現在，如果我們能夠複製 10% 到 20% 的盛行率，這將對我們的業務產生極其有意義的推動力。您必須認識到，仍然有許多醫生認為該患者群體的盛行率接近零。因此，我們今天的發展是透過慢慢教育醫生篩檢和尋找這種疾病來推動的。但我們預計，隨著這些數據的添加，我們將看到這種情況繼續發展。總而言之，我們有許多不同的措施正在實施，但我們正處於看到這些措施價值的早期階段。其中許多才剛起步，我們預計不僅在今年剩餘時間內，而且在 2024 年及以後都會看到成長。

Excellent. I'm looking forward to your best on the CATALYST.

出色的。我期待您在 CATALYST 上取得最好的成績。

Thank you, Joon.

謝謝你，瓊。

All right. Well, listen, thank you all for tuning in this quarter. Happy day after Halloween. And we look forward to seeing you in 3 months with really progress once again. Bye-bye.

好的。好吧，聽著，謝謝大家在本季的調音。萬聖節過後快樂的一天。我們期待在 3 個月後再次見到您取得真正的進步。再見。

Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.

感謝您參加今天的會議。這確實結束了該程式。您現在可以斷開連線。