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Operator
Operator
Thank you for standing by, and welcome to Corcept Therapeutics third-quarter 2025 earnings conference call. (Operator Instructions) I would now like to hand the call over to Atabak Mokari, CFO. Please go ahead.
感謝您的耐心等待,歡迎參加 Corcept Therapeutics 2025 年第三季財報電話會議。(操作員指示)我現在將電話交給財務長阿塔巴克·莫卡里。請繼續。
Atabak Mokari - Chief Financial Officer, Treasurer
Atabak Mokari - Chief Financial Officer, Treasurer
Hello, everyone. Good afternoon, and thank you for joining us. 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.
大家好。下午好,感謝各位的參與。今天,我們發布新聞稿,公佈了第三季的財務業績,並提供了公司最新動態。副本可在 corcept.com 取得。我們的完整財務表現將在向美國證券交易委員會提交 10-Q 表格時公佈。
Today's call is being recorded. A replay will be available at the Investors Past Events tab of our website. We will also post a presentation regarding our oncology development programs in the same section.
今天的通話將會被錄音。您可以在我們網站的「投資者往期活動」標籤中查看回放。我們也將在同一版塊發布有關我們腫瘤學研發專案的簡報。
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, 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.
本次電話會議中除歷史事實陳述外的所有陳述均為前瞻性陳述,這些陳述基於我們的計劃和預期,存在風險和不確定性,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聲明的風險和不確定性已在我們的 10-K 表格年度報告和 10-Q 表格季度報告中進行了描述,所有這些報告都可以在美國證券交易委員會的網站上查閱。更多資訊請參閱相關文件。我們不承擔更新前瞻性陳述的任何意圖或義務。
Our revenue in the third quarter of 2025 was $207.6 million compared to $182.5 million in the prior year period. We have modified our 2025 revenue guidance to $800 million to $850 million. Net income was $19.7 million compared to $47.2 million in the third quarter of last year. Our cash and investments at September 30 were $524 million, which reflects our acquisition of $50 million of our common stock in the third quarter pursuant to our stock repurchase program as well as shares acquired upon the exercise of Corcept stock options and the vesting of restricted stock grants.
2025 年第三季度,我們的營收為 2.076 億美元,而去年同期為 1.825 億美元。我們將 2025 年營收預期調整為 8 億至 8.5 億美元。淨收入為 1,970 萬美元,而去年第三季為 4,720 萬美元。截至 9 月 30 日,我們的現金和投資為 5.24 億美元,這反映了我們在第三季根據股票回購計畫收購了 5,000 萬美元的普通股,以及因行使 Corcept 股票選擇權和限制性股票授予歸屬而獲得的股份。
I will now turn the call over to Charlie Robb, our Chief Business Officer. Charlie?
現在我將把電話轉交給我們的商務長查理羅布。查理?
Charlie Robb - Chief Business Officer
Charlie Robb - Chief Business Officer
Thanks, Atabak. There is nothing new to report regarding our patent litigation with Teva Pharmaceuticals. Recall that in March 2018, we sued Teva to stop it from marketing a generic version of Korlym in violation of our patents.
謝謝,阿塔巴克。關於我們與梯瓦製藥的專利訴訟,目前沒有任何新的進展需要報告。回想一下,在 2018 年 3 月,我們起訴了 Teva 公司,阻止其違反我們的專利銷售 Korlym 的仿製藥。
The case went to trial in September 2023, and in December 2023, the trial court ruled against us. We appealed that decision to the Federal Circuit Court of Appeals. Three judge panel of that court heard oral argument on July 7 of this year.
本案於 2023 年 9 月開庭審理,2023 年 12 月,審判法院判決我們敗訴。我們已就該裁決向聯邦巡迴上訴法院提起上訴。該法院的三名法官組成的小組於今年7月7日聽取了口頭辯論。
Although it is impossible to say exactly when the court will issue its decision, enough time has passed that it is reasonable to say that the decision could come at any time. If we prevail, Teva will lose FDA approval of its product until the expiration of our patent in 2037. We strongly believe our position is correct and are eager to advance this appeal.
雖然無法確切地說法院何時會作出裁決,但時間已經過去足夠長的時間,因此可以合理地認為裁決隨時可能作出。如果我們勝訴,Teva 的產品將失去 FDA 的批准,直到我們的專利在 2037 年到期。我們堅信我們的立場是正確的,並渴望推進這項上訴。
I'll now turn the call over to Sean Maduck, the President of our Endocrinology division. Sean?
現在我將把電話交給內分泌科總裁肖恩·馬杜克。肖恩?
Sean Maduck - President - Corcept Endocrinology
Sean Maduck - President - Corcept Endocrinology
Thanks, Charlie. Our hypercortisolism business had another quarter of robust growth. In the third quarter, we shipped more tablets to patients than ever before, 42.5% higher than the third quarter of last year, driven by yet another record of prescriptions written for Korlym.
謝謝你,查理。我們的高皮質醇症業務又一個季度實現了強勁成長。第三季度,我們向患者交付的藥片數量比以往任何時候都多,比去年第三季度增長了 42.5%,這主要得益於 Korlym 處方量的再次創紀錄增長。
Importantly, our base of prescribers has expanded substantially over the last two years. In summary, the underlying strength of our business continues to build.
重要的是,在過去兩年裡,我們的處方醫生群體已大幅擴大。總而言之,我們業務的潛在實力持續增強。
Our financial results don't fully reflect the surge in demand. I discussed on the last few calls, the insufficient capacity of our previous pharmacy vendor. While we expected their capacity to improve in the third quarter, it did not, which is why we have begun transitioning our business to a new pharmacy in the fourth quarter.
我們的財務表現並未完全反映出需求的激增。在最近幾次通話中,我討論了我們先前的藥局供應商產能不足的問題。雖然我們預期他們的產能會在第三季有所改善,但實際情況並非如此,因此我們從第四季開始將業務轉移到新的藥房。
While capacity constraints may continue for the next few months as we complete the transition, we are very encouraged by the new pharmacy's abilities and its capacity to meet demand. As welcome as such improvements are, eventually the growth we anticipate will outstrip the capacity of any single pharmacy, which is why we plan to add a second specialty pharmacy to our network in January and to onboard a third pharmacy shortly thereafter.
儘管在接下來的幾個月裡,隨著過渡工作的完成,產能限制可能會繼續存在,但我們對新藥房的能力及其滿足需求的能力感到非常鼓舞。儘管這些改進值得歡迎,但我們預計的成長最終將超過任何一家藥局的容量,因此我們計劃在 1 月在我們的網路中增加第二家專科藥局,並在不久後引入第三家藥局。
Our confidence in continued and accelerating growth is based on several factors. The first is growing physician awareness of hypercortisolism. For many years, the prevalence of hypercortisolism and the serious risk it poses for patients were not well understood. As a result, physicians only screened for and treated the most physically obvious cases of the disorder.
我們對持續加速成長的信心是基於以下幾個因素。首先是醫生對高皮質醇症的認識不斷提高。多年來,高皮質醇症的普遍性及其對患者構成的嚴重風險並未被充分認識。因此,醫生只對那些身體症狀最明顯的病例進行篩檢和治療。
In the last 15 years, many studies have shown that hypercortisolism is much more common and is a serious threat to health and far more than the most extreme cases. Most recently, our CATALYST study confirmed these findings, proving that there are many more patients with hypercortisolism than previously assumed and that treatment with a cortisol modulator is highly effective improving their condition, even when other medications, including the newest diabetes medications such as Ozempic and Mounjaro have not.
在過去的 15 年裡,許多研究表明,高皮質醇症更為常見,並且對健康構成嚴重威脅,遠遠超過最極端的病例。最近,我們的 CATALYST 研究證實了這些發現,證明患有高皮質醇症的患者比之前認為的要多得多,而且使用皮質醇調節劑治療可以非常有效地改善他們的病情,即使其他藥物(包括最新的糖尿病藥物,如 Ozempic 和 Mounjaro)沒有效果。
The CATALYST results have been published in Diabetes Care, the field's leading journal and are now being absorbed by the broader physician community. To translate these insights into patient impact, we continue to expand our physician education efforts, and we have enlarged the size of our sales force to 150 clinical specialists, up from 60 at the beginning of 2024.
CATALYST 研究結果已發表在糖尿病照護領域權威期刊《糖尿病照護》上,目前正被更廣泛的醫師群體所接受。為了將這些見解轉化為對患者的影響,我們不斷擴大對醫生的教育工作,並將銷售團隊的規模從 2024 年初的 60 名臨床專家擴大到 150 名臨床專家。
With the awareness of hypercortisolism growing and the effectiveness of cortisol modulation demonstrated in a large placebo-controlled trial published in a leading peer-reviewed journal, I eagerly anticipate relacorilant's approval. Korlym is a great medication but relacorilant is even better.
隨著人們對高皮質醇症的認識不斷提高,以及一項發表在領先的同行評審期刊上的大型安慰劑對照試驗證明了皮質醇調節的有效性,我熱切期盼 relacorilant 獲得批准。Korlym是一種很好的藥物,但relacorilant更好。
It will be a terrific option for both prescribers and patients. I expect that almost all patients who are receiving Korlym will choose to transition to relacorilant and our growth will accelerate.
對於處方醫生和患者來說,這將是一個絕佳的選擇。我預計幾乎所有接受 Korlym 治療的患者都會選擇轉而接受 relacorilant 治療,我們的成長速度將會加快。
I've never been more confident in both our current and future commercial growth and most important, our potential to help many more patients. In the next three to five years, I believe 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,以及最重要的,我們幫助更多患者的潛力,從未像現在這樣充滿信心。我相信,在未來三到五年內,relacorilant 僅在高皮質醇症領域每年就能創造 30 億至 50 億美元的收入。
I will now turn the call over to Joe Belanoff, our Chief Executive Officer. Joe?
現在我將把電話交給我們的執行長喬貝拉諾夫。喬?
Joseph Belanoff - President, Chief Executive Officer, Co-Founder, Director
Joseph Belanoff - President, Chief Executive Officer, Co-Founder, Director
Thank you, Sean, and thank you, everyone, for joining us this afternoon. After many years dedicated to studying the potential of cortisol modulation to help patients suffering from serious diseases, we are on the cusp of a new era at Corcept.
謝謝肖恩,也謝謝各位今天下午的到來。Corcept 多年來致力於研究皮質醇調節對患有嚴重疾病的患者的潛力,如今我們正處於一個新時代的開端。
We have two new drug applications that are rapidly approaching their FDA target action or PDUFA dates. Our NDA for relacorilant as a treatment for patients with hypercortisolism has a PDUFA date of December 30, 2025. Our NDA for relacorilant as a treatment for women with platinum-resistant ovarian cancer has a PDUFA date of July 11, 2026.
我們有兩項新藥申請正迅速接近 FDA 的目標審批日期或 PDUFA 日期。我們針對治療高皮質醇症患者的 relacorilant 的新藥申請 (NDA) 的 PDUFA 日期為 2025 年 12 月 30 日。我們針對鉑金抗藥性卵巢癌女性患者提交的 relacorilant 新藥申請的 PDUFA 日期為 2026 年 7 月 11 日。
We believe the FDA will meet both deadlines. We submitted the European analog to our ovarian cancer NDA, known as a marketing approval authorization, or MAA, to the European Medical -- Medicines Agency, or EMA in October with a regulatory decision likely by year-end 2026.
我們相信FDA能夠準時完成這兩個任務。我們於 10 月向歐洲藥品管理局 (EMA) 提交了針對卵巢癌的歐洲類似藥物的新藥申請 (NDA),即上市許可授權 (MAA),預計到 2026 年底將獲得監管部門的決定。
Some of our most advanced clinical studies will soon produce important data. Our MOMENTUM trial, which is evaluating the prevalence of hypercortisolism in patients with resistant hypertension will have results early next year. We expect final overall survival results from ROSELLA, our pivotal trial in platinum-resistant ovarian cancer around the same time.
我們一些最先進的臨床研究即將產生重要數據。我們正在進行的 MOMENTUM 試驗旨在評估難治性高血壓患者中高皮質醇血症的盛行率,該試驗將於明年初得出結果。我們預計在同一時間左右會公佈 ROSELLA 的最終總生存期結果,這是一項針對鉑耐藥性卵巢癌的關鍵性試驗。
By the end of 2026, we expect results of our BELLA trial also in patients with advanced ovarian cancer as well as results from MONARCH, our Phase 2b trial in patients with MASH, a life-threatening liver disorder.
到 2026 年底,我們預計將公佈 BELLA 試驗在晚期卵巢癌患者中的試驗結果,以及 MONARCH 試驗(一項針對 MASH 患者,一種危及生命的肝臟疾病的 2b 期試驗)的試驗結果。
We are also about to start important new studies. In consultation with the regulators, we are finalizing the design of a Phase 3 trial of our proprietary selective cortisol modulator, dazucorilant in patients with ALS. We plan to start this trial by the middle of next year with a simple goal of replicating the strong results we saw in DAZALS, our Phase 2 trial.
我們即將啟動一些重要的新研究。我們正在與監管機構協商,最終確定我們專有的選擇性皮質醇調節劑達祖可蘭特治療 ALS 患者的 3 期試驗方案。我們計劃在明年年中開始這項試驗,目標很簡單,就是複製我們在 DAZALS(我們的 2 期試驗)中看到的良好結果。
Our oncology program is about to expand significantly beyond platinum-resistant ovarian cancer. The success of ROSELLA provides clear evidence that cortisol-directed therapies have substantial potential in oncology.
我們的腫瘤治療計畫即將大幅擴展,不再局限於鉑類抗藥性卵巢癌。ROSELLA 的成功提供了明確的證據表明,針對皮質醇的療法在腫瘤學領域具有巨大的潛力。
What comes next in oncology is a unique sequencing challenge because the opportunities are so large. We have spent many months giving careful thought to a long-term development plan in oncology that is both methodical and ambitious and most important, will best position Corcept to help as many patients as possible.
接下來腫瘤學領域的發展面臨獨特的序列挑戰,因為機會實在太多了。我們花了數月時間認真思考了腫瘤學領域的長期發展計劃,該計劃既有條不紊又雄心勃勃,最重要的是,它將使 Corcept 能夠更好地幫助盡可能多的患者。
I'm going to ask Bill Guyer, our Chief Development Officer, to describe what he and his team have planned. Bill?
我將請我們的首席發展長比爾·蓋爾介紹他和他的團隊的計劃。帳單?
William Guyer - Chief Development Officer
William Guyer - Chief Development Officer
Thanks, Joe. Now in order to understand the scope of our opportunity in oncology, I think it helps to recall that our program follows ground-breaking insights made by investigators at the University of Chicago, who hypothesized that cortisol activity at the glucocorticoid receptor promotes solid tumor growth in three ways.
謝謝,喬。為了理解我們在腫瘤學領域的機會範圍,我認為有必要回顧一下,我們的計畫是遵循芝加哥大學研究人員的突破性見解而開展的,他們假設皮質醇在糖皮質激素受體上的活性通過三種方式促進實體瘤的生長。
First, it's anti-apoptotic, so it blunts the effectiveness of chemotherapy. Second, it provides alternative growth pathways for prostate cancer tumors being treated with androgen deprivation medication. And third, it suppresses the immune system, reducing the effectiveness of immunotherapy in the treatment of cancer.
首先,它具有抗細胞凋亡作用,因此會削弱化療的效果。其次,它為接受雄性激素剝奪藥物治療的前列腺癌腫瘤提供了替代生長途徑。第三,它會抑制免疫系統,降低免疫療法在癌症治療中的有效性。
Increasing apoptosis by blunting cortisol activity is a very broad platform. It applies to all solid tumors that express the glucocorticoid receptor. Published research has shown that about 60% of solid tumors express the GR, and they do so at every stage of treatment.
透過抑制皮質醇活性來增加細胞凋亡是一個非常廣泛的策略。它適用於所有表達糖皮質激素受體的實體腫瘤。已發表的研究表明,約 60% 的實體腫瘤表達 GR,並且在治療的每個階段都會表達 GR。
Our oncology program is built on the belief that antagonizing the effects of cortisol at the GR can benefit many, many more patients. And a prime example of that is shown by the women from our Phase 2 and pivotal Phase 3 ROSELLA studies who received relacorilant in addition to nab-paclitaxel and experienced extended progression-free survival and live longer than the women who were treated with just nab-pac alone.
我們的腫瘤治療方案基於這樣的理念:透過拮抗糖皮質激素受體(GR)上的皮質醇作用,可以使更多的患者受益。一個典型的例子是,我們 2 期和關鍵性 3 期 ROSELLA 研究中的女性,她們除了接受 nab-paclitaxel 治療外還接受了 relacorilant 治療,她們的無進展生存期延長,並且比只接受 nab-pac 治療的女性活得更久。
Now remember, nab-pac is one of the most potent treatments for women with this disease, and adding relacorilant led to an even better result and remarkably without adding to the safety burden of the women who received it. Adverse events with relacorilant plus nab-pac were comparable in type, frequency and severity to nab-pac monotherapy. As I review the data, relacorilant is a remarkably well-tolerated drug.
請記住,nab-pac 是治療這種疾病女性最有效的藥物之一,而添加 relacorilant 則帶來了更好的效果,而且令人驚訝的是,並沒有增加接受治療的女性的安全負擔。relacorilant 合併 nab-pac 治療的不良事件在類型、頻率和嚴重程度上與 nab-pac 單藥治療相當。根據我的數據,雷拉可利蘭是一種耐受性非常好的藥物。
The medical field understands the importance of our results because the data from ROSELLA were presented at high-profile forums this year, including late-breaking oral sessions at both ASCO and ESMO annual meetings. And ROSELLA findings were published in The Lancet, one of the world's most preeminent journals.
醫學界了解我們研究結果的重要性,因為 ROSELLA 的數據今年在備受矚目的論壇上進行了展示,包括在美國臨床腫瘤學會 (ASCO) 和歐洲腫瘤內科學會 (ESMO) 年會上的最新口頭報告。ROSELLA 的研究結果發表在世界頂尖期刊之一的《柳葉刀》。
Our goal now is to undertake studies that will extend this work in three ways: first, in earlier lines of therapy for ovarian cancer; second, in new types of solid tumors; and third, combining our proprietary GR antagonist with additional regimens. So the first study advancing this goal is the Phase 2 BELLA trial. BELLA's initial objective is to treat and test the additional benefit of relacorilant may bring when combining it with nab-pac as well as bevacizumab, which is a potent drug that is commonly used to treat patients with platinum-resistant ovarian cancer.
我們現在的目標是進行研究,從三個方面擴展這項工作:首先,在卵巢癌的早期治療中;其次,在新型實體瘤中;第三,將我們專有的 GR 拮抗劑與其他療法結合起來。因此,推進此目標的首個研究是 BELLA 二期試驗。BELLA 的初步目標是治療和測試 relacorilant 與 nab-pac 以及貝伐珠單抗(一種常用於治療鉑耐藥性卵巢癌患者的強效藥物)聯合使用時可能帶來的額外益處。
Due to the strong interest in our program by investigators around the world, this study has enrolled patients much faster than we expected. And as Joe mentioned, we will have the results by the end of 2026. But this is just our first step. BELLA's protocol allows us to add more arms to the study that include patients with different types of solid tumors.
由於世界各地的研究人員對我們的計畫表現出濃厚的興趣,這項研究的患者招募速度比我們預期的要快得多。正如喬所提到的,我們將在 2026 年底前得到結果。但這只是我們的第一步。BELLA 的方案可讓我們在研究中加入更多組別,其中包括患有不同類型實體瘤的患者。
Currently, we are going to add two new arms. The first will evaluate relacorilant plus nab-pac and bevacizumab to treat patients with platinum-sensitive ovarian cancer, an earlier stage of the disease. In order to enroll in this arm, patients must have progressed on a PARP inhibitor, which is the subgroup that experienced profound benefit in ROSELLA, and we just presented that data at the ESMO conference.
目前,我們將新增兩個分支機構。第一項研究將評估 relacorilant 合併 nab-pac 和貝伐單抗治療鉑敏感卵巢癌患者(此疾病的早期階段)的療效。要加入該組,患者必須在使用 PARP 抑制劑後病情有所進展,而這一亞組在 ROSELLA 研究中獲得了顯著的益處,我們剛剛在 ESMO 會議上公佈了這些數據。
The second new BELLA arm will evaluate the potential of relacorilant plus nab-pac to treat patients with endometrial cancer. Separately, we are also initiating a Phase 2 study of relacorilant plus nab-pac in patients with cervical cancer in collaboration with ARCAGY-GINECO, which is an academic clinical research group specializing in gynecological cancers. These new studies will enable us to triple the potential number of women with gynecological cancers that we can help each year in the United States from 20,000 patients with platinum-resistant ovarian cancer to 60,000 patients.
BELLA 的第二個新分支將評估 relacorilant 加 nab-pac 治療子宮內膜癌患者的潛力。另外,我們也與專門研究婦科癌症的學術臨床研究小組 ARCAGY-GINECO 合作,啟動了 relacorilant 加 nab-pac 治療子宮頸癌患者的 2 期研究。這些新的研究將使我們能夠每年在美國幫助的婦科癌症患者人數增加兩倍,從 20,000 名鉑耐藥性卵巢癌患者增加到 60,000 名患者。
We are also targeting other tumors with significant unmet medical needs. We are initiating a Phase 2 study in patients with pancreatic cancer by combining relacorilant with the first-line standard of care regimen of nab-pac and gemcitabine.
我們也正在關注其他存在重大未滿足醫療需求的腫瘤。我們正在啟動一項針對胰臟癌患者的 2 期研究,將 relacorilant 與第一線標準治療方案 nab-pac 和吉西他濱聯合使用。
All of these studies will begin enrollment in the coming weeks and should enroll very quickly like all of our past studies have done. The results will be guideline enabling with a particular focus on the National Comprehensive Cancer Network or NCCN guidelines. These studies will also inform our future development decisions.
所有這些研究都將在未來幾週內開始招募受試者,並且應該會像我們過去的所有研究一樣,很快就招募到足夠的受試者。研究結果將有助於制定指導方針,尤其側重於國家綜合癌症網絡(NCCN)指南。這些研究成果也將為我們未來的發展決策提供基礎。
In addition to exploring cortisol receptors antagonism potential to resensitize tumors to chemotherapy, we are evaluating its use in combination with antigen deprivation therapy. 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 to determine if GR antagonism can block a cortisol-mediated tumor escape route.
除了探討皮質醇受體拮抗劑使腫瘤對化療重新敏感的潛力外,我們還在評估其與抗原剝奪療法合併使用的療效。我們在芝加哥大學的合作者目前正在招募早期前列腺癌患者,進行一項隨機安慰劑對照的 2 期試驗,研究 relacorilant 加 enzalutamide 的療效,以確定 GR 拮抗劑是否可以阻斷皮質醇介導的腫瘤逃脫途徑。
Another possible role of cortisol receptor antagonism is in combination with immunotherapy. Immunotherapy has emerged as a standard of care cancer treatment with more than 200,000 patients in the United States receiving this form of therapy each year. Because cortisol suppresses the immune system, it may blunt the effectiveness of cancer therapies intended to stimulate an immune response. Adding a GR antagonist to immunotherapy may enhance their effectiveness.
皮質醇受體拮抗劑的另一個可能作用是與免疫療法合併使用。免疫療法已成為癌症治療的標準療法,美國每年有超過 20 萬名患者接受這種療法。由於皮質醇會抑制免疫系統,因此可能會削弱旨在刺激免疫反應的癌症療法的療效。在免疫療法中加入糖皮質激素受體拮抗劑可能會增強其療效。
Therefore, in the coming weeks, we are initiating a Phase 1b dose-finding study of nenocorilant, our new proprietary selective cortisol receptor antagonist in combination with nivolumab, a PD-1 directed immunotherapy to treat patients with a broad range of solid tumors.
因此,在接下來的幾週內,我們將啟動一項 1b 期劑量探索研究,研究我們新開發的專有選擇性皮質醇受體拮抗劑 nenocorilant 與 PD-1 靶向免疫療法 nivolumab 聯合用藥,以治療患有多種實體瘤的患者。
We've embarked on a mission to advance GR antagonism to help many patients with a broad range of solid tumors. Our ROSELLA study produced exciting confirmatory evidence of our hypothesis, and there is much more to come. We look forward to updating you on our progress.
我們致力於推動 GR 拮抗劑療法,以幫助許多患有各種實體瘤的患者。我們對 ROSELLA 的研究為我們的假設提供了令人興奮的證實證據,而且還有更多成果即將到來。我們期待向您報告我們的進展。
I'll now turn the call back over to Joe.
現在我將把電話轉回給喬。
Joseph Belanoff - President, Chief Executive Officer, Co-Founder, Director
Joseph Belanoff - President, Chief Executive Officer, Co-Founder, Director
Thanks, Bill. Before reporting advances in our MASH and ALS programs, I will briefly describe the research findings that give us confidence in the substantial opportunity before us in our hypercortisolism franchise.
謝謝你,比爾。在報告我們在 MASH 和 ALS 計畫的進展之前,我將簡要介紹研究結果,這些結果讓我們對高皮質醇症領域面臨的巨大機會充滿信心。
Prevalence phase of our CATALYST trial demonstrated that one in four patients with resistant diabetes has hypercortisolism, a far higher rate than was previously assumed. These results are transforming medicine. Patients who are enrolled in the placebo-controlled treatment phase of CATALYST had uncontrolled diabetes despite treatment with the best current medications administered by the leading diabetologists and hypercortisolism.
我們的 CATALYST 試驗的盛行率階段表明,四分之一的難治性糖尿病患者患有高皮質醇血症,這一比例遠高於先前的預期。這些成果正在改變醫學。參加 CATALYST 安慰劑對照治療階段的患者,儘管接受了頂尖糖尿病專家提供的當前最佳藥物治療,但其糖尿病仍未得到控制,並且患有高皮質醇症。
In 24 weeks, patients treated with Korlym experienced a 1.47% reduction in hemoglobin A1c, along with significant improvements in body weight and waist circumference. Notably, patients in CATALYST experienced these improvements even as they decreased or entirely discontinued their other glucose-lowering medications, including the most potent GLP-1 agonists.
24 週後,接受 Korlym 治療的患者血紅蛋白 A1c 降低了 1.47%,體重和腰圍也得到了顯著改善。值得注意的是,CATALYST 研究中的患者即使減少或完全停止服用其他降血糖藥物(包括最有效的 GLP-1 激動劑),也經歷了這些改善。
Our MOMENTUM trial builds on the findings from CATALYST by evaluating the prevalence of hypercortisolism in patients with resistant hypertension. Results from MOMENTUM are expected by early next year. The findings from CATALYST and MOMENTUM will substantially accelerate screening for hypercortisolism and its treatment.
我們的 MOMENTUM 試驗以 CATALYST 的研究結果為基礎,評估了難治性高血壓患者中高皮質醇血症的盛行率。MOMENTUM 研究結果預計將於明年初公佈。CATALYST 和 MOMENTUM 研究結果將大大加速高皮質醇症的篩檢和治療。
As physician awareness of hypercortisolism rapidly grows, relacorilant is approaching its December 30 PDUFA date. Relacorilant's NDA is supported by our pivotal Phase 3 GRACE trial as well as our GRADIENT long-term extension and Phase 2 trials. In these studies, patients treated with relacorilant experienced clinically meaningful improvements in all the measures of hypercortisolism including hypertension, hyperglycemia, weight, lean muscle mass, waist circumference, cognition, and Cushing's quality of life score.
隨著醫生對高皮質醇症的認識迅速提高,雷拉可利蘭即將迎來 12 月 30 日的 PDUFA 日期。Relacorilant 的新藥申請得到了我們關鍵的 3 期 GRACE 試驗以及 GRADIENT 長期擴展和 2 期試驗的支持。在這些研究中,接受 relacorilant 治療的患者在所有高皮質醇血症指標方面都獲得了具有臨床意義的改善,包括高血壓、高血糖、體重、瘦肌肉量、腰圍、認知能力和庫欣氏生活品質評分。
These benefits were observed consistently and durably with improvements emerging early and continuing or deepening over time. As awareness of hypercortisolism and its ability to be treated grows, many more patients will be identified, and 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.
這些益處持續且持久地顯現出來,改善效果出現得早,並且隨著時間的推移而不斷持續或加深。隨著人們對高皮質醇症及其治療可能性的認識不斷提高,將會發現更多患者,而 Corcept 已做好充分準備來幫助他們。正如肖恩之前所說,我們有信心,我們的庫欣氏症候群業務將在未來幾年繼續成長。
Our proprietary molecule, miricorilant, has very potent activity in the liver. Metabolic dysfunction-associated steatohepatitis, or MASH, is a serious liver disorder that afflicts millions of patients in the United States and globally. Cortisol activity plays a role in both the initial development and progression of the disease and cortisol modulation may serve as a treatment.
我們專有的分子miricorilant在肝臟中具有非常強的活性。代謝功能障礙相關性脂肪性肝炎(MASH)是一種嚴重的肝臟疾病,在美國和全球範圍內影響數百萬名患者。皮質醇活性在疾病的初始發展和進展中都發揮作用,調節皮質醇水平可能是一種治療方法。
Our Phase 1b study showed that miricorilant rapidly reduced liver fat and improved other important markers of liver health, including fibrosis. Miricorilant was also very well tolerated without the GI side effects commonly seen in patients being treated for MASH.
我們的 1b 期研究表明,miricorilant 能迅速減少肝臟脂肪,並改善其他重要的肝臟健康指標,包括纖維化。米利可蘭的耐受性也非常好,沒有出現MASH患者治療中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 enrolled 175 patients in two cohorts. The first cohort of patients has biopsy-confirmed MASH. The second cohort consists of patients with presumed MASH. We expect results from both cohorts late next year.
我們進行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 研究將 175 名患者分為兩個隊列。第一批患者經切片確診為 MASH。第二組患者為疑似患有 MASH 的患者。我們預計兩組受試者的結果將於明年年底公佈。
ALS is a devastating disease associated with elevated cortisol activity. Our proprietary compound, dazucorilant, is an excellent candidate to treat it. In our 249 patient double-blind, placebo-controlled Phase 2 DAZALS trial, patients who received 300 milligrams of dazucorilant exhibited an 84% reduction in the risk of death at the one-year mark compared to patients who only received placebo.
肌萎縮側索硬化症(ALS)是一種與皮質醇活性升高相關的毀滅性疾病。我們專有的化合物達祖可利蘭是治療這種疾病的絕佳候選藥物。在我們針對 249 名患者進行的雙盲、安慰劑對照的 2 期 DAZALS 試驗中,接受 300 毫克達祖可蘭治療的患者在一年時死亡風險比僅接受安慰劑的患者降低了 84%。
The p-value for this finding was 0.0009. This reduction in early death occurs when patients still retain considerable function and quality of life. It does not simply add months to the end of their life when the disease's burden can be enormous.
此結果的p值為0.0009。早期死亡率的降低發生在患者仍保持相當高的功能和生活品質的情況下。它不僅會延長患者幾個月的生命,而這種疾病帶來的負擔可能是巨大的。
As I mentioned earlier, we plan to start a Phase 3 trial in 2026, designed with input from the FDA, European regulators and leading clinicians that simply aims to replicate the results of DAZALS.
正如我之前提到的,我們計劃在 2026 年啟動 3 期試驗,該試驗是在 FDA、歐洲監管機構和領先的臨床醫生的參與下設計的,其目標很簡單,就是複製 DAZALS 的結果。
We covered a great deal today. Let me reiterate our important developments. Next month, we expect FDA approval of relacorilant for the treatment of hypercortisolism. This milestone comes as physicians begin to fully absorb the results of the CATALYST study, which demonstrated that hypercortisolism is far more prevalent than previously recognized and the treatment with a cortisol modulator can significantly improve the health of their patients.
我們今天討論了很多內容。讓我重申一下我們所取得的重要進展。下個月,我們預計 FDA 將批准 relacorilant 用於治療高皮質醇症。這一里程碑的到來,正值醫生開始全面理解 CATALYST 研究的結果之際。該研究表明,高皮質醇症比以前認識到的更為普遍,而使用皮質醇調節劑進行治療可以顯著改善患者的健康狀況。
Our MOMENTUM study will produce results by early next year, building on CATALYST findings. By mid-next year, we anticipate relacorilant's first oncology approval in platinum-resistant ovarian cancer, a particularly challenging form of ovarian cancer. Results from the ROSELLA trial showing improved progression-free and overall survival without additional safety burden are ground breaking.
我們的 MOMENTUM 研究將在 CATALYST 研究結果的基礎上,於明年初公佈結果。預計到明年年中,relacorilant 將首次獲準用於治療鉑抗藥性卵巢癌,這是一種特別棘手的卵巢癌。ROSELLA 試驗的結果顯示,在不增加安全負擔的情況下,無惡化存活期和總存活期均有所改善,這是一項突破性成果。
The fact that cortisol receptor antagonism demonstrated such compelling results in this extremely difficult-to-treat cancer type gives us confidence in its potential across a broad range of tumors and underpins our decision to expand our oncology development portfolio. We expect first results from our new oncology studies by the end of next year.
皮質醇受體拮抗劑在這種極難治療的癌症類型中展現出如此令人信服的效果,這讓我們對其在多種腫瘤中的潛力充滿信心,也鞏固了我們擴大腫瘤學開發組合的決定。我們預計明年年底前將公佈新的腫瘤學研究的初步結果。
Beyond hypercortisolism and oncology, we expect results from a large, controlled study in patients with MASH by the end of next year and plan to initiate a Phase 3 study in patients with ALS by mid-next year. We continue to discover and develop proprietary selective cortisol modulators with likely very distinctive clinical attributes and are advancing the most promising to the clinic.
除了皮質醇增多症和腫瘤學之外,我們預計到明年年底將獲得一項針對 MASH 患者的大型對照研究的結果,併計劃在明年年中啟動一項針對 ALS 患者的 3 期研究。我們不斷發現和開發具有獨特臨床特性的專有選擇性皮質醇調節劑,並將最有希望的藥物推進臨床試驗。
Cortisol modulation's vast potential to help many patients is just beginning to unfold. It is a very exciting time for Corcept. Operator, let's proceed to questions.
皮質醇調節對許多患者的巨大潛力才剛開始展現。對Corcept來說,這是一個令人振奮的時刻。接線員,我們開始提問環節。
Operator
Operator
(Operator Instructions) Edward Nash, Canaccord Genuity.
(操作說明)愛德華·納什,Canaccord Genuity。
Edward Nash - Equity Analyst
Edward Nash - Equity Analyst
I wanted to ask, I know sometimes you give the numbers. I just want to get an idea of how many patients at the end of the quarter that you had on drug? And then also, can you give us some idea of -- I know you're going to be bringing on a second new distributor at the beginning of the year, as you mentioned.
我想問一下,我知道有時候你會給出數字。我只是想了解一下,到季度末,你們有多少患者正在服用這種藥物?另外,您能否透露一下——我知道您提到過,您將在年初引入第二個新的分銷商。
But just wanted to have an idea of based upon what historically your previous distributor, what additional capacity or what magnitude of capacity does this new distributor that sort of come on in October have over your old distributor?
我只是想了解一下,根據您之前的經銷商的歷史數據,這家十月份新加入的經銷商比您之前的經銷商多多少產能或產能規模有多大?
Joseph Belanoff - President, Chief Executive Officer, Co-Founder, Director
Joseph Belanoff - President, Chief Executive Officer, Co-Founder, Director
Thank you, Edward. I think we understand both of those questions. And I'm going to pass you over to Sean Maduck, who is the President of our Endocrinology division.
謝謝你,愛德華。我想我們都理解這兩個問題。接下來我將把發言權交給肖恩·馬杜克,他是我們內分泌科的總裁。
Sean Maduck - President - Corcept Endocrinology
Sean Maduck - President - Corcept Endocrinology
Thanks, Ed. I appreciate the question. Your first question was around about how many patients do we have on medicine at the end of the quarter. We had around 3,250 paying patients at the end of the third quarter.
謝謝你,埃德。我很感謝你的提問。你的第一個問題是關於季度末我們有多少病人正在接受藥物治療。第三季末,我們約有 3250 名付費患者。
So in terms of the pharmacy that was just onboarded on October 1, it's a great pharmacy and we think we're going to -- they're going to do just a fantastic job supporting patients. And they've got about 25 years of experience, which is in serving orphan and orphan disease products, which is great.
所以,就10月1日剛加入的這家藥局而言,它是一家很棒的藥房,我們認為他們將會——他們在支持患者方面做得非常出色。他們擁有大約 25 年的經驗,專門服務於孤兒藥和罕見疾病產品,這很棒。
In terms of the specific question around capacity, they have the ability to continually expand with our business. They also have multiple locations around the country to distribute, which is something that was very appealing to us as we continue through the rest of the year with Korlym and then get ready for the relacorilant launch in 2026.
就產能問題而言,他們有能力隨著我們業務的成長而不斷擴張。他們還在全國各地設有多個分銷點,這對我們來說非常有吸引力,因為我們將繼續在今年剩餘的時間裡銷售 Korlym,然後為 2026 年推出相關產品做好準備。
Joseph Belanoff - President, Chief Executive Officer, Co-Founder, Director
Joseph Belanoff - President, Chief Executive Officer, Co-Founder, Director
And Edward, I think you also asked about other pharmacies, which are coming on next year. I think a really important thing to realize to tie your two questions together as well there are now 3,000 or so patients who are taking Korlym. We actually believe that the market capacity is much, much greater than that.
愛德華,我想你還問到了明年即將開幕的其他藥局。我認為將你的兩個問題聯繫起來非常重要的一點是,目前大約有 3000 名患者正在服用 Korlym。我們實際上認為市場容量遠大於此。
And we really do think that as relacorilant begins to come on to the market, no single pharmacy is going to easily handle all of the business there. And that's why we're gearing up right now to add second, third pharmacies to that.
我們確實認為,隨著瑞可立蘭開始上市,沒有一家藥局能夠輕易處理所有的業務。所以,我們現在正積極籌備,增加第二家、第三家藥局。
Edward Nash - Equity Analyst
Edward Nash - Equity Analyst
Great. That's helpful. And I just had one quick model question. On the gross margin line, you guys have historically had really high margins. And given the increase in volume, but also pricing and generic shift, are you seeing any downward pressure on margins that might require modeling adjustments going forward?
偉大的。那很有幫助。我剛才有一個簡單的示範題。從毛利率來看,你們的毛利率歷來都很高。鑑於銷量增加,以及價格上漲和仿製藥的更迭,您是否看到利潤率面臨任何下行壓力,這可能需要對未來的模型進行調整?
Joseph Belanoff - President, Chief Executive Officer, Co-Founder, Director
Joseph Belanoff - President, Chief Executive Officer, Co-Founder, Director
Let me give you back to Atabak on for that question.
這個問題我得把回覆轉給阿塔巴克。
Atabak Mokari - Chief Financial Officer, Treasurer
Atabak Mokari - Chief Financial Officer, Treasurer
Hi, Edward. No, we have not seen that, and we don't expect that.
你好,愛德華。不,我們沒有看到這種情況,也不認為會發生這種情況。
Operator
Operator
David Amsellem, Piper Sandler.
大衛·阿姆塞勒姆,派珀·桑德勒。
David Amsellem - Analyst
David Amsellem - Analyst
Just a couple of quick ones. One, can you just remind us what the -- what net pricing looks like relative to brand pricing, just given that more and more of the business is going through the AG? How much of your business is coming from the AG?
就簡單問幾個問題。第一,鑑於越來越多的業務都透過 AG 進行,您能否提醒我們一下——相對於品牌定價而言,淨定價是什麼樣的?你們的業務有多少來自農業部?
And then also, as you look to the PDUFA in ovarian, were you surprised you didn't get a priority review? And then lastly, can you talk about R&D and SG&A directionally for 2026 given the launches and given all the clinical studies?
另外,在查看卵巢癌的 PDUFA 時,你是否對沒有獲得優先審查感到驚訝?最後,鑑於產品上市及所有臨床研究,您能否談談 2026 年的研發與銷售、管理及行政費用方向?
Joseph Belanoff - President, Chief Executive Officer, Co-Founder, Director
Joseph Belanoff - President, Chief Executive Officer, Co-Founder, Director
Thanks, David. And I think we'll give your questions to the person who could each answer them best. Sean, why don't you begin?
謝謝你,大衛。我認為我們會把你們的問題交給最適合回答這些問題的人。肖恩,你先開始吧?
Sean Maduck - President - Corcept Endocrinology
Sean Maduck - President - Corcept Endocrinology
Yes. Thanks, David. In terms of our authorized generic in the second quarter, we were -- about two-thirds of our business were on the authorized generic. In the third quarter, it ended in the low 70s. And our expectation is by the end of the year, it might creep up a little bit, maybe ending at around 75%.
是的。謝謝你,大衛。就我們第二季的授權仿製藥而言,我們大約三分之二的業務都來自授權仿製藥。第三季度,數字收在70分出頭。我們預計到年底,這一比例可能會略微上升,最終可能達到 75% 左右。
And then in terms of the net, it's about a 30% discount to Korlym's list price.
淨價方面,比 Korlym 的標價優惠了大約 30%。
Joseph Belanoff - President, Chief Executive Officer, Co-Founder, Director
Joseph Belanoff - President, Chief Executive Officer, Co-Founder, Director
Charlie, answer about the ovarian cancer NDA.
查理,回答一下關於卵巢癌保密協議的問題。
Charlie Robb - Chief Business Officer
Charlie Robb - Chief Business Officer
Yes. So we requested priority review. We didn't receive it. And to say, we weren't surprised to not receive it. We wouldn't have been surprised to receive it.
是的。因此我們申請了優先審查。我們沒有收到。說實話,我們沒收到並不感到意外。收到這份禮物我們並不感到驚訝。
Just based on the strength of the application, we were confident that we met the sort of stated criteria about substantial benefit in terms of safety or efficacy over available treatments. But the FDA has many priorities, many other things going on and their decisions are theirs and are sometimes opaque to us.
僅憑申請書的質量,我們就確信我們符合既定的標準,即在安全性和有效性方面比現有療法具有實質優勢。但是,FDA有很多優先事項,還有很多其他事情要處理,他們的決定是他們自己的,有時對我們來說並不透明。
So no, not surprised. Always hopeful, not surprised. And that's just, I think, the way dealing with the FDA on this kind of question has to be.
所以,我並不感到驚訝。永遠抱持希望,並不感到驚訝。我認為,在這類問題上與美國食品藥物管理局(FDA)打交道就必須如此。
Joseph Belanoff - President, Chief Executive Officer, Co-Founder, Director
Joseph Belanoff - President, Chief Executive Officer, Co-Founder, Director
And Atabak?
還有阿塔巴克?
Atabak Mokari - Chief Financial Officer, Treasurer
Atabak Mokari - Chief Financial Officer, Treasurer
Sure. So regarding your question on R&D spend and SG&A, so we've talked a lot about the huge opportunity that we see ahead of us on multiple fronts across all of our businesses. And so we're going to invest to capture that.
當然。關於您提出的研發支出和銷售、管理及行政費用問題,我們已經多次談到了我們在所有業務的多個方面所看到的巨大機會。因此,我們將進行投資以獲取這一機會。
So on the R&D side, while we -- Bill walked you through many new studies that we're planning, there are many studies that we've been running throughout this year that are completing and winding down. So I would expect our R&D expenditures next year to be about the same as we are in 2025.
所以在研發方面,雖然我們——比爾向你們介紹了我們正在計劃的許多新研究,但我們今年一直在進行的許多研究正在完成和結束。因此,我預計我們明年的研發支出將與 2025 年的研發支出大致相同。
And then on the SG&A side, we see huge opportunities on both hypercortisolism and ovarian cancer. And so we've been investing to prepare for launches of relacorilant in both of those indications, and we'll continue to invest to capture the large market opportunity. So I would expect those SG&A expenses to continue to increase.
在銷售、一般及行政費用方面,我們看到了高皮質醇症和卵巢癌領域的巨大機會。因此,我們一直在投資,為 relacorilant 在這兩種適應症中的上市做準備,我們將繼續投資,以抓住巨大的市場機會。因此,我預計銷售、管理及行政費用將持續成長。
Operator
Operator
Joon Lee, Truist Securities.
Joon Lee,Truist Securities。
Asim Rana - Analyst
Asim Rana - Analyst
Congrats on the quarter. This is Asim Rana on for Joe. Just a couple from us. So you said previously that the second pharmacy would have more meaningful contribution in the fourth quarter. Now that the first pharmacies out of the picture seems to be, how confident are you that Curant can handle the increase in volume over, say, fourth quarter and the quarters going forward?
恭喜你本季取得佳績。這是阿西姆·拉納為喬報道。我們這裡還有幾條訊息。所以你之前說過,第二家藥局將在第四季做出更有意義的貢獻。既然第一批藥局似乎已經退出市場,您對 Curant 能否應對第四季及以後幾季的業務量成長有多大信心?
Is Curant fully online as of the fourth quarter? And then just as a follow-up, on the upcoming PDUFA for relacorilant, have you had a late cycle review for relacorilant? And if so, what can you share?
Curant 從第四季開始是否已完全實現線上營運?那麼,作為後續問題,關於即將進行的 relacorilant 的 PDUFA 審查,您是否對 relacorilant 進行了後期週期審查?如果可以,您能分享些什麼?
Joseph Belanoff - President, Chief Executive Officer, Co-Founder, Director
Joseph Belanoff - President, Chief Executive Officer, Co-Founder, Director
Sure. Thank you very much for those questions. I think I understand all of them. The first one, we will send to Sean.
當然。非常感謝您提出的這些問題。我想我全都聽懂了。第一份,我們將寄給肖恩。
Sean Maduck - President - Corcept Endocrinology
Sean Maduck - President - Corcept Endocrinology
Yes. So I'll answer your second question first. Curant is fully online. They started taking new patients on October 1. Almost all new enrollments are going to Curant.
是的。那我先回答你的第二個問題。Curant 已全面上線。他們從10月1日開始接收新病人。幾乎所有新生都去了柯蘭特學院。
And over the course of the quarter, we will be transitioning the remainder of the business. So we're very confident in their ability to handle the capacity and meet the demands of the fourth quarter.
在本季度內,我們將逐步完成剩餘業務的過渡。因此,我們對他們處理產能和滿足第四季需求的能力非常有信心。
Joseph Belanoff - President, Chief Executive Officer, Co-Founder, Director
Joseph Belanoff - President, Chief Executive Officer, Co-Founder, Director
And Charlie?
查理呢?
Charlie Robb - Chief Business Officer
Charlie Robb - Chief Business Officer
So just can you repeat the question for me because I want to make sure I answer it really correctly. What you say?
所以,你能再重複一次這個問題嗎?因為我想確保我的回答完全正確。你說的話?
Asim Rana - Analyst
Asim Rana - Analyst
Yes. Just on the upcoming PDUFA for relacorilant, have you had a late cycle review for rela? And if so, what can you share?
是的。關於即將生效的瑞拉可蘭特(relacorilant)的PDUFA(處方藥用戶付費法案),您是否接受過瑞拉可蘭特的後期治療方案審查?如果可以,您能分享些什麼?
Charlie Robb - Chief Business Officer
Charlie Robb - Chief Business Officer
Sure. So just a little background for people who don't -- are not as familiar with NDAs as you are. When the FDA agrees to review your new drug application, they give you a letter that sets out sort of the key milestones that are going to happen during the review process. And one of them is the mid-cycle review meeting with -- between the sponsor and the FDA. And the second is, as you know, another one is this late cycle review meeting.
當然。所以,這裡簡單介紹一下背景知識,給那些不太了解保密協議的人一些參考。當 FDA 同意審查你的新藥申請時,他們會給你一封信,其中列出了審查過程中將要發生的關鍵里程碑。其中之一是贊助商與 FDA 之間的中期審查會議。第二個,如你所知,是後期週期審查會議。
I can tell you that we've had both. I cannot tell you sort of what transpired or the nature of our back and forth with the FDA because we just can't comment on that. But we held them both exactly on the schedule the FDA set out in additional -- in its original letter to us. Things have moved per schedule, very ordinary course, and we are very confident as a result that the FDA will meet its target date of December 30.
我可以告訴你,我們兩種情況都經歷過。我無法告訴你具體發生了什麼,也無法告訴你我們與FDA之間的來回溝通情況,因為我們對此不予置評。但我們完全按照 FDA 在最初給我們的信中補充說明的時間表進行了這兩項試驗。事情進展順利,一切都在按計劃進行,非常正常,因此我們非常有信心,FDA 將按期在 12 月 30 日之前完成批准。
Asim Rana - Analyst
Asim Rana - Analyst
And if I could just have a quick follow-up. Is Optime still selling Korlym? And if so, like how long would they have to?
如果可以的話,我想再問一個後續問題。Optime還在銷售Korlym嗎?如果是這樣,他們大概要花多久時間?
Joseph Belanoff - President, Chief Executive Officer, Co-Founder, Director
Joseph Belanoff - President, Chief Executive Officer, Co-Founder, Director
Yes. Sean, please take that.
是的。肖恩,請拿著。
Sean Maduck - President - Corcept Endocrinology
Sean Maduck - President - Corcept Endocrinology
So Optime is still servicing patients just as they were before as they're obligated by the contract.
因此,Optime 仍然像以前一樣為患者提供服務,因為他們有合約義務這樣做。
Operator
Operator
RK, HC Wainwright.
RK,HC Wainwright。
Swayampakula Ramakanth - Analyst
Swayampakula Ramakanth - Analyst
A couple of questions. So first question being on the guidance. If I take the midpoint of your current guidance, the fourth quarter sales should come around $265 million or so, which is -- which means it requires a 28% growth from the third quarter number. With only one pharmacy in operation per se, how comfortable are you in thinking about that sort of growth, especially with holidays and less number of sales days? And the second question --
幾個問題。首先,關於指導方針的問題。如果我採用您目前預測的中點,第四季銷售額應該在 2.65 億美元左右,這意味著需要比第三季成長 28%。目前只有一家藥局在運營,您對這種成長有多大把握?尤其是在假日和銷售天數減少的情況下?第二個問題--
Joseph Belanoff - President, Chief Executive Officer, Co-Founder, Director
Joseph Belanoff - President, Chief Executive Officer, Co-Founder, Director
Go ahead, please.
請繼續。
Swayampakula Ramakanth - Analyst
Swayampakula Ramakanth - Analyst
Sorry. And the second question is on the new molecule that I see on the pipeline, nenocorilant, how different is that from rela? And do you plan to release any preclinical data from that molecule as we start thinking about the study in solid tumors as a combination therapy with the PD-1 inhibitors?
對不起。第二個問題是關於我在研發管線中看到的新分子nenocorilant,它與rela有什麼不同?在我們開始考慮將該分子與 PD-1 抑制劑聯合用於實體瘤治療的研究之際,您是否計劃公佈該分子的任何臨床前數據?
Joseph Belanoff - President, Chief Executive Officer, Co-Founder, Director
Joseph Belanoff - President, Chief Executive Officer, Co-Founder, Director
Okay. I think we have both of those questions. The first one is Sean. Please go ahead, Sean.
好的。我認為我們有兩個問題。第一個是肖恩。請繼續,肖恩。
Sean Maduck - President - Corcept Endocrinology
Sean Maduck - President - Corcept Endocrinology
Yes. So RK, just to be clear, you said in your question that we only have one pharmacy. That's incorrect. We actually have two pharmacies. Optime Care is continuing to service the active patient base and all new prescriptions are going to Curant.
是的。所以 RK,為了確認一下,你在問題中說我們只有一家藥局。這是錯誤的。我們實際上有兩家藥房。Optime Care 將繼續為現有患者提供服務,所有新處方都將送至 Curant。
So over time, a greater percentage of our business is going to transfer over there. We expect combined to see some efficiencies, and we expect to have a strong Q4.
因此,隨著時間的推移,我們越來越多的業務將會轉移到那裡。我們預計合併後效率會有所提高,並預期第四季業績將表現強勁。
Joseph Belanoff - President, Chief Executive Officer, Co-Founder, Director
Joseph Belanoff - President, Chief Executive Officer, Co-Founder, Director
And Bill, any comments you'd like to make about nenocorilant?
比爾,你對新諾可利蘭有什麼想說的嗎?
William Guyer - Chief Development Officer
William Guyer - Chief Development Officer
Yes. Thank you. So related to nenocorilant in our oncology portfolio, when we look at relacorilant, as you heard, all the studies we're doing with relacorilant. Relacorilant is a great molecule and it's shown its benefit not only in oncology, but also endocrinology, but we're always looking at and evaluating new molecules preclinically to help us broaden our reach in every therapeutic area and especially oncology.
是的。謝謝。所以,就我們腫瘤產品組合中的新可利蘭而言,當我們審視瑞可利蘭時,正如你所聽到的,我們正在對瑞可利蘭進行所有研究。Relacorilant 是一種很棒的分子,它不僅在腫瘤學領域,而且在內分泌學領域也顯示出了益處,但我們一直在臨床前研究和評估新的分子,以幫助我們擴大在每個治療領域,特別是腫瘤學領域的應用範圍。
And as we looked at the opportunity with combinations with PD-1 inhibitors, we felt that a drug like nenocorilant had unique properties that allowed us to dose it on a regular basis to help us look at other solid tumors. And we really felt it was the best partner for PD-1 inhibitors compared to that of relacorilant.
當我們研究與 PD-1 抑制劑合併用藥的機會時,我們認為像 nenocorilant 這樣的藥物具有獨特的特性,可以讓我們定期給藥,以幫助我們研究其他實體瘤。我們真心覺得,與 relacorilant 相比,它是 PD-1 抑制劑的最佳搭檔。
And so when it comes to publishing our preclinical data, yes, we always publish our data. And I would expect us to have that data in the public domain next year.
所以,在發布我們的臨床前數據方面,是的,我們總是會發布我們的數據。我預計明年我們將能夠公開這些數據。
Joseph Belanoff - President, Chief Executive Officer, Co-Founder, Director
Joseph Belanoff - President, Chief Executive Officer, Co-Founder, Director
Let me make just a more general point because I know, obviously, RK is really the first person who really absorbed our oncology opportunity. You've been following this the longest than anybody, but let me make some points for those who have not.
讓我再說一個更普遍的觀點,因為我知道,很顯然,RK 是第一個真正抓住我們腫瘤學機會的人。你關注這件事的時間比任何人都長,但我想為那些不了解的人說幾點。
One of the really interesting things is that years ago, when we were only working with mifepristone, which we call Korlym, we were looking for a follow-on compound, which wouldn't have progesterone receptor activity. And our terrific Chief Chemist at that point -- now our Chief Scientific Officer, Hazel Hunt -- was able to come up with one and then more and then more.
一件非常有趣的事情是,幾年前,當我們只研究米非司酮(我們稱之為 Korlym)時,我們正在尋找一種後續化合物,這種化合物不會具有孕激素受體活性。當時我們傑出的首席化學家——現在的首席科學官 Hazel Hunt——想出了一個,然後又想出了更多,再想出了更多。
And what was really interesting about them is that while all of those compounds modulated cortisol activity and none of them touch the progesterone receptor. So they were really distinct. She sort of accomplished her mission in separating the activities.
真正有趣的是,雖然所有這些化合物都能調節皮質醇活性,但它們都無法作用於黃體素受體。所以它們之間確實存在著很大的差異。她基本上完成了將這些活動分開的任務。
As we began to test them preclinically, they simply weren't identical. Some got into the brain, some didn't get into the brain, some were organ-specific, some were general and some were more potent in the -- on various oncology models than others.
當我們開始進行臨床前測試時,發現它們根本不相同。有些藥物進入了大腦,有些藥物沒有進入大腦,有些藥物具有器官特異性,有些藥物具有普遍性,有些藥物在各種腫瘤模型中比其他藥物更有效。
And so where it left us with not a single follow-on compound, which is frankly what I had anticipated but with four, five, six, seven compounds, each paired with the best treatment opportunity and best disorder for which it could make progress.
因此,最終我們沒有得到任何後續化合物,坦白說,這正是我所預期的,但我們卻得到了四、五、六、七種化合物,每一種都與最佳治療機會和最佳疾病相匹配,可以取得進展。
So it's been a very interesting opportunity. I think nenocorilant is quite interesting. You'll learn more about it next year as we go along. We're very excited to actually begin that study. I think it will really help us learn very much as to what the next thing to do is.
所以,這是一個非常有趣的機會。我覺得新可利蘭特很有意思。明年隨著專案的推進,你會了解更多相關資訊。我們非常興奮能夠真正開始這項研究。我認為這真的會幫助我們了解下一步該做什麼。
So thank you all for your questions. Thank you for listening in. Really an exciting time, and I look forward to talking to you next quarter. Thank you. Bye-bye.
謝謝大家的提問。謝謝收聽。這真是一個令人興奮的時刻,我期待下個季度與您交流。謝謝。再見。
Operator
Operator
This concludes today's conference call. Thank you for participating. You may now disconnect.
今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線了。