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美國
證券交易委員會
華盛頓特區20549
_______________________________________________________
表格 10-Q
_______________________________________________________
根據1934年證券交易法第13或15(d)節的季度報告
截至季度結束日期的財務報告2024年9月30日
或者
根據1934年證券交易法第13或15(d)節的轉型報告書
過渡期從             到                
委員會檔案號碼:
000-50679
_______________________________________________________
CORCEPT THERAPEUTICS INCORPORATED
(公司章程中指定的確切公司名稱)
_______________________________________________________
特拉華州77-0487658
(國家或其他管轄區的
公司成立或組織)
(IRS僱主
唯一識別號碼)
Redwood Shores Parkway 101號
Redwood City, 加利福尼亞州 94065
(總部地址,包括郵政編碼)
_______________________________________________________
(650) 327-3270
(註冊人電話號碼,包括區號)
_______________________________________________________

根據法案第12(b)條註冊的證券:
每一類的名稱交易標誌在其上註冊的交易所的名稱
普通股,每股0.001美元面值CORT納斯達克證券交易所 LLC
請勾選以下選項,以表明要件:(1)在過去12個月內(或在註冊者需要提交這些報告的較短時期內)已提交1934年證券交易法13或15(d)節要求提交的所有報告,並且(2)在過去90天內一直需要提交此類報告。  ☒    否  ☐
請用複選標記表示,登記者在過去的12個月中(或者對於登記者需要提交這些文件的更短時期),是否已按照《S-T規定第405條》的規定提交了應提交的每個交互數據文件。  ☒    否  ☐
請勾選標記以說明註冊人是大型快速申報人、加速申報人、非加速申報人、較小的報告公司還是新興成長型公司。請查看《交易所法》第120億.2條中「大型快速申報人」、「加速申報人」、「較小的報告公司」和「新興成長型公司」的定義。
大型加速報告人加速文件申報人
非加速文件提交人更小的報告公司
成長型公司
如果是新興成長公司,請在複覈者處標明勾選符號,說明註冊者是否選擇不使用依據證券交易法第13(a)條規定提供的任何新的或修訂後的財務會計準則的擴展過渡期。 ☐
請勾選以下內容。申報人是否是外殼公司(根據證券交易法規則12b-2定義)。    是      否  ☒
2024年10月23日,有 104,775,137 每股面值爲$0.001的普通股。




目錄

2

第一部分 財務信息
項目1。基本報表
corcept醫療公司
簡明合併資產負債表
(以千爲單位)
2020年9月30日
2024
12月31日
2023
 (未經審計)(見注1)
資產  
流動資產:  
現金及現金等價物$137,289 $135,551 
短期市場證券243,047 232,670 
應收賬款,扣除準備金59,717 41,123 
與Melucci訴訟相關的保險賠款應收款(注4) 14,000 
庫存8,050 7,730 
預付費用和其他流動資產18,875 27,562 
總流動資產466,978 458,636 
戰略庫存7,764 8,244 
經營租賃資產使用權5,503 120 
資產和設備,淨值2,930 195 
長期有價證券167,310 57,176 
其他6,973 6,541 
126,799 90,605 
總資產$784,257 $621,517 
負債和股東權益
流動負債:
應付賬款$18,584 $17,396 
應計研發費用27,736 21,330 
應計負債及其他負債79,464 51,628 
與Melucci訴訟相關的應計結算(附註4) 14,000 
短期租賃負債432 151 
流動負債合計126,216 104,505 
長期經營租賃負債6,359  
長期應計所得稅應付款12,847 10,307 
負債合計145,422 114,812 
承諾和或因應事項(注4)
股東權益:
優先股  
135 133 
自家保管的股票(682,177)(635,078)
額外實收資本806,317 738,515 
累計其他綜合收益1,571 609 
保留盈餘512,989 402,526 
股東權益總額638,835 506,705 
負債和股東權益總額$784,257 $621,517 
隨附說明是這些簡明合併財務報表的一部分。
3

corcept醫療公司
簡明合併利潤表
(未經審計)
(以千爲單位,除每股數據外)
截至9月30日的三個月截至9月30日的九個月
 2024202320242023
產品收入,扣除折扣$182,546 $123,601 $493,150 $346,970 
營業費用:
銷售成本2,867 1,645 7,926 4,604 
研發59,336 45,517 176,587 129,646 
銷售、一般及行政費用73,745 45,262 196,948 137,107 
營業費用總計135,948 92,424 381,461 271,357 
營業利潤46,598 31,177 111,689 75,613 
利息和其他收入6,345 5,208 17,844 12,135 
稅前收入52,943 36,385 129,533 87,748 
所得稅費用(5,730)(5,007)(19,070)(12,963)
淨收入47,213 31,378 110,463 74,785 
歸屬於普通股股東的淨收益46,690 31,172 109,344 74,353 
每股基本淨利潤$0.45 $0.31 $1.06 $0.72 
每股稀釋淨利潤$0.41 $0.28 $0.98 $0.66 
用於計算每股普通股淨利潤的加權平均股份
基本103,371 102,014 103,094 103,933 
稀釋的113,723 111,099 111,571 112,054 
隨附說明是這些簡明合併財務報表的一部分。
4

corcept醫療公司
綜合收益簡明合併報表
(未經審計)
(以千爲單位)
截至9月30日的三個月截至9月30日的九個月
 2024202320242023
淨收入47,213 31,378 110,463 74,785 
其他綜合收益(損失):
可供出售投資的未實現收益(損失),減稅效果後的淨額($256), $31, $(139) and $(184和), 分別爲
951 (95)432 586 
外匯翻譯收益(損失)536 (184)530 49 
總綜合收益$48,700 $31,099 $111,425 $75,420 
相關附註是這些基本報表的一個不可或缺的部分。
5

corcept醫療公司
簡明財務報表現金流量表
(未經查核)
(以千為單位)
 截至9月30日的九個月
 20242023
經營活動現金流量:  
凈利潤$110,463 $74,785 
調整淨利潤以達經營活動所提供之淨現金流量:
股份報酬44,558 35,875 
證券投資折價(溢價)之累積差異(8,747)(5,933)
折舊與攤提514 828 
推延所得稅(36,333)(25,821)
租賃權資產攤銷362 1,262 
營運資產和負債的變化:
應收貿易款項(18,594)(3,569)
與Melucci訴訟有關的保險索償應收款項14,000  
存貨383 936 
預付費用及其他流動資產8,462 (5,579)
其他資產(432) 
應付賬款1,616 4,783 
研發費用已列入費用6,406 6,732 
應計利益及其他負債27,531 36,695 
與Melucci訴訟相關的應計和解(14,000) 
長期應計所得稅2,540 1,373 
營業租賃負債38 (1,215)
經營活動產生的淨現金流量138,767 121,152 
投資活動之現金流量:
購買不動產和設備(2,051)(139)
來自可銷售證券到期所得332,545 372,793 
可銷售證券的購入(443,738)(298,846)
投資活動提供的淨現金流量(使用)(113,244)73,808 
來自籌資活動的現金流量:
來自股票期權行使的收入,扣除發行成本後的淨額3,268 1,091 
員工股票購買計劃下的購買收入3,927 2,959 
與股份回購計劃相關的普通股回購(15,664) 
在收購要約中回購普通股 (145,428)
支付現金以滿足免現金期權行使及受限制股授予的法定扣繳要求(15,316)(8,111)
籌集資金的淨現金流量(23,785)(149,489)
現金及現金等價物淨增加1,738 45,471 
現金及現金等價物期初餘額135,551 66,329 
現金及現金等價物期末餘額$137,289 $111,800 

6

補充揭露:
行使回購的股票成本,用於無現金選擇權行使的淨結算$14,184 $22,199 
相關附註是這些基本報表的一個不可或缺的部分。
7

corcept醫療公司
股東權益簡明合併財務報表
(未經查核)
(以千為單位)
普通股額外的
實收資本
資本
庫藏股累計
其他
綜合
收入(損失)
保留收益總計
股東权益
股權
股份金額
2023年12月31日餘額103,405 $133 $738,515 $(635,078)$609 $402,526 $506,705 
根據激勵獎計劃發行普通股786 — 3,485 — — — 3,485 
股份用於滿足現金無償期權行使及限制股解鎖時的成本和法定代扣要求(143)— 2,032 (5,586)— — (3,554)
與股份回購計劃相關的普通股回購(20)— — (476)— — (476)
與凈股回購相關的奢華稅— — — 81 — — 81 
股份報酬— — 12,929 — — — 12,929 
與員工股票購買計劃相關的限制股解鎖— — 1,283 — — — 1,283 
其他全面損失,扣除稅後淨額— — — — (351)— (351)
凈利潤— — — — — 27,762 27,762 
2024年3月31日止結餘104,028 $133 $758,244 $(641,059)$258 $430,288 $547,864 
根據激勵獎勵計畫發行普通股份700 1 7,573 — — — 7,574 
股份用於支付現金期權行使和受限股解除的成本和法定代扣要求,以進行無現金結算(208)— — (6,242)— — (6,242)
根據股票回購計畫回購普通股份(122)— — (3,478)— — (3,478)
與淨股份回購相關的消費稅— — — 16 — — 16 
股份報酬— — 13,881 — — — 13,881 
與員工股票購買計畫中受限股解除相關的股票頒發— — 1,314 — — — 1,314 
其他全面損失,扣除稅後淨額— — — — (174)— (174)
凈利潤— — — — — 35,488 35,488 
2024年6月30日餘額104,398 $134 $781,012 $(650,763)$84 $465,776 $596,243 
根據激勵獎勵計劃發行普通股1,175 1 10,321 — — — 10,322 
股份被提供以滿足現金期權行使和受限制股解除須支付成本及法定扣繳要求的淨結算(526)— — (19,704)— — (19,704)
在股票回購計畫中回購普通股(344)— — (11,710)— — (11,710)
股份報酬— — 14,286 — — — 14,286 
受員工股票購買計劃之限制性股解除的分配— — 698 — — — 698 
其他綜合收益,稅後— — — — 1,487 — 1,487 
凈利潤— — — — — 47,213 47,213 
2024年9月30日結餘104,703 $135 $806,317 $(682,177)$1,571 $512,989 $638,835 
相關附註是這些基本報表的一個不可或缺的部分。
8

普通股額外的
實收資本
資本
庫藏股累計
其他
綜合
收入(損失)
保留收益總計
股東权益
股權
股份金額
2022年12月31日結餘107,835 $131 $662,342 $(456,148)$(869)$296,386 $501,842 
根據激勵獎勵計劃發行普通股份618 — 6,540 — — — 6,540 
股份被提供以滿足現金無現金選擇權行使的成本和法定扣繳要求(297)— — (6,359)— — (6,359)
股份報酬— — 10,966 — — — 10,966 
其他綜合收益,稅後— — — — 716 — 716 
凈利潤— — — — — 15,879 15,879 
2023年3月31日結束餘額108,156 $131 $679,848 $(462,507)$(153)$312,265 $529,584 
根據激勵獎勵計劃發行普通股份1,168 1 4,496 — — — 4,497 
股份被提供以滿足現金無現金選擇權行使的成本和法定扣繳要求(202)— — (4,823)— — (4,823)
回購普通股與要約收購相關(6,610)— — (145,428)— — (145,428)
與凈利潤份額回購相關的貨物稅— — — (1,316)— — (1,316)
股份報酬— — 11,374 — — — 11,374 
其他綜合收益,稅後— — — — 198 — 198 
凈利潤— — — — — 27,528 27,528 
2023年6月30日結餘102,512 $132 $695,718 $(614,074)$45 $339,793 $421,614 
在獎勵計劃下發行普通股1,068 1 13,949 — — — 13,950 
購買股份以滿足無現金期權行使的成本和法定代扣需求(584)— — (17,866)— — (17,866)
與凈利潤分享回購相關的消費稅— — — 152 — — 152 
股份報酬— — 11,660 — — — 11,660 
與員工股票認購計劃相關的限制性股票授予— — 1,070 — — — 1,070 
其他全面損失,扣除稅後淨額— — — — (279)— (279)
凈利潤— — — — — 31,378 31,378 
截至2023年9月30日的結餘102,996 $133 $722,397 $(631,788)$(234)$371,171 $461,679 
隨附說明是這些簡明合併財務報表的一部分。
9

corcept醫療公司
未經審計的縮編合併財務報表附註
1. 報告的編制基於美國公認會計原則(US GAAP)和證券交易委員會(SEC)的適用規則和法規,關於中期財務報告的規定。根據這些規定的規定,某些按照美國公認會計原則通常要求的註腳或其他財務信息已被精簡或省略,因此2024年1月31日的資產負債表及相關披露信息已來源於那個日期的經審計合併財務報表,但不包含美國公認會計原則要求的所有信息。這些未經審計的簡明合併財務報表與公司的年度合併財務報表基於相同的基礎而編制,經管理層的意見,反映了必要的調整(僅包括正常循環調整),以公平呈現公司的簡明合併財務信息。2024年4月30日的營業結果不一定是預期的2025年1月31日或任何其他中期或未來年度的結果。
業務說明及基本準則
corcept醫療公司(以下簡稱「Corcept」,「本公司」,「我們」和「我們的」)是一家從事發現和開發藥物治療嚴重內分泌、腫瘤、代謝和神經系統疾病的商業階段藥品公司,通過調節激素皮質醇的作用。2012年,美國食品藥品監督管理局(「FDA」)批准Korlym®(米非司酮)300毫克片,作爲一種每日一次的口服藥物,用於治療因內源性庫欣氏綜合徵導致的高血糖的成人患者,這些患者患有2型糖尿病或葡萄糖不耐受,並且手術失敗或不適合手術。2024年6月,我們推出了Korlym的授權通用版本,用於相同適應症。我們已發現並擁有專利的 四個具有結構獨特的選擇性皮質醇調節劑系列,包括超過1,000化合物。我們正在開發這些系列化合物,作爲潛在治療廣泛嚴重疾病的藥物。
我們公司成立於1998年5月份,在加利福尼亞州雷德伍德城設有總部。
報告範圍
我們按照美國通用會計準則("GAAP")和《10-Q表格》的指示和《S-X法規》第10條準則準備了以下臨時基本報表:(i)截至2024年9月30日的簡明綜合資產負債表,以及(ii)截至2024年9月30日和2023年的三個和九個月的簡明綜合收入、綜合收益和股東權益表,以及(iii)截至2024年9月30日和2023年的九個月的簡明綜合現金流量表。這些報表不包括所有基本報表所需的信息和附註。據管理層意見,包括了爲了公平呈現所需的所有調整(適用期間僅包括正常、重複性調整)。截至2024年9月30日的三個和九個月的運營結果不一定代表2024年其餘時間或其他任何期間的結果。這些基本報表和附註應當與2023年12月31日結束的年度財務報表一併閱讀,這些財務報表包含在我們的《10-K表格》年度報告中。2023年12月31日的資產負債表來源於當日的審計基本報表。
重要會計政策的描述在截至2023年12月31日的年度10-k表格中未發生重大變化。
最近發佈的未採納會計準則
2023年12月,財務會計準則委員會(「FASB」)發佈了會計準則更新(「ASU」)No. 2023-09,要求報告實體的有效稅率調和信息進行細分,以及有關所繳所得稅的信息。該準則旨在通過提供更詳細的所得稅披露,有助於投資者做出資本配置決策。這項ASU適用於在2024年12月15日後年度起的上市公司,允許提前採納。我們計劃在2025年12月31日結束的財政年度採納這一指引。我們目前正在評估採納這項指引將對簡明一體化財務報表產生的影響。
2023年11月,FASB發佈了ASU No. 2023-07,旨在改善關於上市實體可報告部門的披露,並滿足投資者對可報告部門費用的額外、更詳細信息的要求。該標準適用於年度開始於2023年12月15日後的上市公司,對於2024年12月15日後年度開始的財年內的中期期間則允許提前採納。我們將在2024年12月31日結束的年度期間及此後的中期期間採納這項指導。首席執行官是我們的首席經營決策者,我們將我們的經營和管理業務視爲一個經營部門。
10

2. 特定資產負債表項目的組成
庫存
2020年9月30日
2024
12月31日
2023
 (以千爲單位)
進行中的工作7,764 8,233 
成品8,050 7,741 
19,78215,814 15,974 
少量戰略庫存分類爲非流動資產(7,764)(8,244)
總庫存被歸類爲流動資產$8,050 $7,730 
我們依靠 製造商爲我們的藥物生產活性藥物成分(「API」)。我們已經購買並持有大量的 API,包括在建庫存中。我們將預計在資產負債表之日起 12 個月內不會出售的庫存歸類爲 「戰略庫存」,即非流動資產。
預付費用和其他流動資產
2020年9月30日
2024
12月31日
2023
(以千爲單位)
預付費用$5,817 $4,319 
延期處理臨床資料5,707 13,496 
臨床存款2,771 3,865 
其他資產4,580 5,882 
預付款和其他流動資產總計$18,875 $27,562 
應計負債及其他負債
2020年9月30日
2024
12月31日
2023
 (以千爲單位)
政府返利$38,799 $18,468 
應計的薪資27,568 25,457 
已計銷售與營銷成本3,959 1,771 
法律費用1,836 542 
其他7,302 5,390 
已計應付及其他負債總額$79,464 $51,628 
其他
截至2024年9月30日和2023年12月31日,其他資產包括$6.0萬美元和6.4 用於臨床試驗的存款分別爲百萬美元。
11

3. 可供出售金融資產和公允價值衡量
我們的簡明綜合資產負債表中可供出售證券如下:
2020年9月30日
2024
12月31日
2023
(以千爲單位)
現金等價物$110,789 $97,170 
短期市場證券243,047 232,670 
長期有價證券167,310 57,176 
總計可出售證券$521,146 $387,016 
以下表格按資產類型分組列出了我們可供出售證券:
 公允價值
等級制度
級別
2024年9月30日2023 年 12 月 31 日
攤銷成本未實現收益總額未實現虧損總額估計公允價值攤銷成本未實現收益總額未實現虧損總額估計公允價值
  (以千計)
公司債券第 2 級$300,504 $836 $(87)$301,253 $120,508 $307 $ $120,815 
商業票據第 2 級4,875 12  4,887 75,308 20 (9)75,319 
美國國債第 1 級104,171 46  104,217 93,655 61 (4)93,712 
貨幣市場基金第 1 級110,789   110,789 97,170   97,170 
有價證券總額$520,339 $894 $(87)$521,146 $386,641 $388 $(13)$387,016 
我們根據來自商業定價服務的報價市場價格,估計將被分類爲1級的有市場價值的證券的公允價值;我們使用可能包括基準收益率、報告的交易、經紀商/交易商報價和發行人利差的輸入,估計將被分類爲2級的有市場價值的證券的公允價值。
我們定期審查我們的債務安防-半導體,以確定是否有任何投資由於發行人的信用不良或其他原因而受損。如果我們的投資的公允價值低於其攤銷成本,我們將評估定量和主觀因素-包括但不限於安全性質、信用評級變化和關於安全性發行人和行業的分析師報告、利率波動和一般市場情況-以確定是否需要對信用損失提取撥備。
我們的所有投資,包括未實現損失的投資,均未受損。投資的未實現損失是由於利率波動引起的。我們不打算賣出當前存在未實現損失的投資,並且在其攤銷成本基礎得到收回之前,我們幾乎不太可能出售任何投資,這可能發生在其到期後。因此,我們未爲這些投資錄入信用減值準備。
我們將市場證券的應計利息分類爲資產2.9萬美元和1.7 million在2024年9月30日和2023年12月31日分別被確認爲預付款和其他流動資產,記錄在我們的簡明合併資產負債表中。
截至2024年9月30日,我們所有的長期可流通證券的原始到期日不超過 26 個月,所有分類爲短期的可流通證券的到期日均低於 一年。我們短期和長期可流通證券的加權平均到期日爲 十個月 。截至2024年9月30日,我們的長期可流通證券剩餘到期日介於 13在我們的年報(Form 10-K)中描述的合同協議方面,沒有實質性的變化。24 個月之間。截至2024年9月30日,我們的可流通證券在過去3個月和9個月內沒有從一個公平值分層轉換爲另一個。
4. 承諾和事後約定
在截至2023年12月31日的年度10-k報告中描述的合同協議下,我們的義務沒有發生實質性變化。
在業務的正常過程中,我們可能會面臨法律訴訟和監管行動,這可能會對我們的業務或財務狀況產生重大不利影響。我們通過分析潛在的情況來評估在此類情況下的潛在責任
12

在各種訴訟、監管和和解策略下的結果。如果我們判斷可能會發生損失,並且可以合理估計損失金額,我們會計提相應金額等於估計損失金額。
Melucci訴訟和解決方案
2019年3月14日,尼古拉斯·梅魯奇(Nicholas Melucci)向美國加利福尼亞北區地方法院提起了所謂的證券集體訴訟(Melucci 訴 Corcept Therapeutics Incorporated 等,第 5:19 號案例-cv-01372-LHK)(「梅魯奇訴訟」)。該投訴將我們和我們的某些執行官列爲被告,指控他們違反了《交易法》第10(b)和20(a)條以及根據該法頒佈的第100億條第5條,並指控被告作出了虛假和具有重大誤導性的陳述,沒有披露有關我們業務、運營和前景的負面事實。該投訴稱,假定集體訴訟期從2017年8月2日延長至2019年2月5日,並要求提供未指明的金錢救濟、利息和律師費。2019年10月7日,法院任命了首席原告和首席律師。首席原告的合併申訴於2019年12月6日提出。
2023年2月8日,我們原則上達成了一項協議(「擬議和解」)以解決Melucci訴訟中的所有索賠。如先前披露的,我們根據擬議和解支付了一次性款項$14.0百萬至第三方託管帳戶,該款項爲擬議和解所要求,我們的保險公司後來已全額退還了我們這筆款項。2024年6月6日,美國加利福尼亞北部地區聯邦地方法院法官James Donato批准了擬議和解的最終認可,該和解將管理向原告類成員支付的款項。
損失和 迄今已記錄爲損失準備金。有關我們正在進行的法律事項的進一步信息,請參閱 第二部分第1項,法律訴訟。
5. 租約
2024 年 4 月,我們簽訂了 六年 向Zuora, Inc.轉租(「轉租」),用於位於加利福尼亞州雷德伍德城紅木海岸公園大道101號的辦公空間,自2024年7月1日起生效。租賃的物業成爲我們的新總部,自 2024 年 8 月 1 日起生效。受轉租約約束的房屋部分是 50,632 可出租的平方英尺。由於擁有搶先體驗權,轉租於2024年6月1日開始,並將於2030年6月30日結束。我們有義務支付平均$的基本租金1.5在租賃期內每年一百萬美元。根據該協議,我們根據未來租賃付款的現值記錄了與租賃財產相關的使用權資產和相應的租賃負債。
我們在加利福尼亞Menlo Park的前總部租約於2024年8月31日到期。對於租期在12個月及以下的租賃,我們不承認使用權資產或租賃負債,而是按照直線法在租賃期內在簡明綜合收入表中確認相關的租賃付款。因此,由於剩餘租期不足12個月,我們沒有記錄與我們的前總部相關的額外使用權資產和相應的租賃負債。
由於我們的設施經營租賃合同未提供足夠的信息來確定隱含借貸利率,我們使用折現率計算了剩餘租賃支付的現值,折現率等於我們支付具有月度支付和期限等於月度支付和剩餘租期的抵押貸款上的利率。經營租賃使用權資產還包括在開始日期之前支付的任何租金,扣減任何獲得的租賃激勵。我們使用直線法在租賃期內識別經營租賃支付爲費用。
2024年9月30日結束的三個月和九個月的經營租賃費用分別爲$0.7萬美元和2.1萬美元,較上年同期的0.6萬美元和1.8 百萬美元,在2023年相應時期內。
與經營租賃相關的補充信息如下(單位:千美元,除加權平均數外):
截至9月30日的三個月,截至9月30日的九個月
2024202320242023
經營租賃負債的現金支付$ $617 $1,358 $1,774 
認可權益資產以交換租賃責任$ $297 $5,745 $297 
加權平均剩餘租賃期限696個月96個月
加權平均折扣率8.5 %8.0 %
截至2024年9月30日,非可取消的資本化經營租賃的未來最低租賃付款如下(以千爲單位):
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2024(餘數)$ 
20251,382 
20261,551 
20271,598 
20281,646 
此後2,555 
減:表示利息的金額8,732 
減去隱含利息(1,941)
營業租賃負債現值$6,791 
6. 股東權益
庫存股
2024年1月,我們的董事會批准了一個計劃,授權回購高達$的普通股。200 該計劃授權的回購金額可在公開市場、私下協商的交易或其他形式中進行。任何回購的時間和金額將根據市場條件、我們的股價和其他因素確定。該計劃不要求我們回購任何特定數量的股份,並且可以根據需要隨時修改、暫停或終止,無需事先通知。
在截至2024年9月30日的三個月和九個月內,我們購買了 0.30.5萬股普通股,在股票回購計劃下通過公開市場交易平均價格爲$34.02 和 $32.25 每股,分別爲購買總價$11.7萬美元和15.7 萬股普通股。截至2024年9月30日,尚有授權可用於回購我們的普通股。184.3 萬美元。
我們按成本在我們的簡明綜合資產負債表上記錄已購股票。截至2024年9月30日和2023年12月31日,我們持有 32.430.9百萬股庫存股。
激勵計劃
我們有之一 股權獎勵計劃 - corcept醫療公司2024激勵獎勵計劃(「2024計劃」)。
2024年2月,我們的董事會批准了2024年計劃,在2024年5月17日舉行的股東年會上獲得股東批准後生效,並取代了corcept醫療公司的2012年激勵獎勵計劃(「2012計劃」)。根據2024年計劃授予或轉讓的獎勵所涉及的股份總數等於(i)xxx百萬股,(ii)xxx百萬股,這等於2024年5月17日2012計劃下未來授予的股份數量,以及(iii)2012計劃下未來授予的任何獎勵,截至2024年5月17日或之後因任何原因而終止,到期或失效而未向持有人交付股份。 2024年5月17日後,將不再根據2012計劃發放任何額外獎勵。 8.0百萬股, 4.1百萬股,這等於2024年5月17日2012計劃下未來授予的股份數量,以及2012計劃下未來授予的任何獎勵,在2024年5月17日或之後終止、到期或失效而未向持有人交付股份。2024年5月17日後,將不再根據2012計劃發放任何額外獎勵。
根據2024年計劃,我們可以向員工、高管、董事和顧問發行股票期權、股票購買權、股票增值權和限制性股票獎勵。
股票期權
截至2024年9月30日止的三個月和九個月內,我們發行了 1.01.8 百萬股普通股,對應行使期權。部分期權持有人按「淨行使」方式行使其期權,根據該方式,他們向我們交出,我們按當時市價從他們那裏購買,價值等於相關行使價格和稅款扣除義務的股票。截至2024年9月30日止的三個月和九個月內,我們分別購買了 0.50.8百萬股股票,用於此類期權淨行使,並支付了10.5萬美元和12.2百萬美元,分別用於支付相關稅款扣除義務。
在截至2023年9月30日的三個月和九個月期間,我們發行了 1.02.0各自發行了百萬股普通股進行期權行使。一些期權持有人以「淨行使」方式行使了他們的期權,根據該方式,他們向我們交出,並且我們按當時的市場價格從他們購買了價值等同於相關行使價格和稅金代扣義務的股份。截至2023年9月30日的三個月和九個月期間,我們
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購買0.61.1分別交易了200萬股、500萬股的期權及支付了$4.21百萬美元和6.8分別支付了1000萬美元以滿足相關的稅款代扣義務。
限制性股票獎勵(「RSA」)
截至2024年9月30日的三個月和九個月,我們向員工授予了 0.20.8百萬限制性股票獎勵,加權平均授予日公允價值爲$34.58 和 $27.07 每股的分享,分別。截至2023年9月30日的三個月和九個月,我們向員工授予了 0.10.5百萬限制性股票獎勵,加權平均授予日公平價值爲$26.96 和 $23.26 每股應享有的投票以及分紅權責。因此,RSAs被視爲「享有權」股份,用於計算基本和攤薄每股淨利潤。請參閱下文中的「第7條註釋」。
員工股票購買計劃(「ESPP」)
我們的 ESPP 允許員工通過工資扣除的方式預留最多 他們購買我們普通股的年度薪酬的百分比。股票於3月1日、6月1日、9月1日和12月1日(或者,如果這些日期是節假日或週末,則在之後的第一個工作日)向2024年計劃的參與員工發行,按當時交易收盤時確定的我們股票當時的公允市場價值。
對於每一股購買的股票,參與員工將獲得一股配套股票,如果符合特定條件,則還可以從2024年計劃中發行。根據ESPP購買而發行的股份無需歸屬要求。配套股票將以RSA形式授予,將在對應ESPP購買日期的週年紀念日上歸屬,淨扣除適用的稅款。 一年 RSA的歸屬條件是參與員工需持有自ESPP購買日起的若干年的相應股票。根據ESPP購買的股票和任何配套股票可以由員工自行保留、出售或轉讓。 一年 根據ESPP購買的股份和任何配套股票可以由員工全權決定保留、出售或轉讓。
截至2024年9月30日和2023年12月31日,我們在未經審計的簡明綜合資產負債表中的"應計及其他負債"項下,分別負有$2.7萬美元和2.3 百萬美元的以RSAs形式授予的股權補償相關的責任。
2021年6月,公司採用了2021年員工、董事和顧問股權激勵計劃(「2021計劃」),並進行了修改,授權公司授予最多83,564股普通股。2022年,公司修改了2021計劃,並將計劃授權的股票總數增加至2,748,818股。2024年1月,公司採用了2024年員工、董事和顧問股權激勵計劃(「2024計劃」),授權公司授予最多3,900,000股普通股,加上2021計劃中剩餘的未授予或被放棄的股票。截至2024年3月31日,還有3,939,333股可供授予。公司的股票期權根據授予協議中的條款授予,通常按比例贈與。
以下表格總結了我們按帳戶分類的股權報酬情況:
截至9月30日的三個月截至9月30日的九個月
 2024202320242023
 (以千計)
資本化股票薪酬$95 $44 $223 $170 
銷售成本24 11 49 43 
研究和開發4,660 4,023 13,018 11,169 
銷售、一般和管理11,418 8,841 31,491 24,663 
股票薪酬總額$16,197 $12,919 $44,781 $36,045 
7. 每股淨收益
我們按照參與股份的公司所需的兩類股本計算基本和攤薄每股淨利潤。 根據兩類股本法,淨利潤通過將淨利潤分配給普通股和未獲授予的RSA之間來確定。 我們通過將歸屬於普通股股東的淨利潤除以期間內流通的平均普通股數量來計算基本每股淨利潤。 我們通過將歸屬於普通股股東的淨利潤除以期間內流通的平均普通股數量來計算攤薄每股淨利潤,包括可能具有攤薄效應的股票期權和未獲授予的受限制股票單位(「RSU」),減去未獲授予的RSA。 我們使用庫存法來確定由股票期權和未獲授予的RSU導致的普通股攤薄股數。
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以下表格顯示了每個時期每股淨利潤的計算:
截至9月30日的三個月截至9月30日的九個月
 2024202320242023
 (以千爲單位,每股金額除外)
分子:  
歸屬於普通股股東的淨收益$46,690 $31,172 $109,344 $74,353 
分母:
用於計算普通每股淨利潤的加權平均份額103,371 102,014 103,094 103,933 
員工期權和未授予RSU的攤薄效應10,352 9,085 8,477 8,121 
用於計算每股稀釋淨利潤的加權平均股份113,723 111,099 111,571 112,054 
每股基本淨利潤$0.45 $0.31 $1.06 $0.72 
每股稀釋淨利潤$0.41 $0.28 $0.98 $0.66 
截至2024年9月30日,我們擁有 25.0 百萬股票期權, 1.2 百萬限制性股票獎勵, 0.1 百萬限制性股票單位待發放。截至2023年9月30日,我們持有 23.3 百萬股票期權, 0.7 百萬限制性股票獎勵, 0.1 百萬限制性股票單位待發放。
在加權平均基礎上排除了在2024年9月30日結束的三個月和九個月中的未行使的百萬股期權,以計算稀釋每股淨利潤。1.0500萬股,並且總成本(包括佣金和消費稅)分別爲$8.6 分別在截至2024年9月30日的三個月和九個月以及截至2023年9月30日的三個月和九個月中,我們排除了未行使的百萬股期權,因爲包含它們會降低稀釋效果。 6.3500萬股,並且總成本(包括佣金和消費稅)分別爲$9.0 分別在截至2023年9月30日的三個月和九個月中,我們排除了未行使的百萬股期權,因爲包含它們會降低稀釋效果。
8. 所得稅
2024 年6月30日和2023 年6月30日的期權式股票競爭行權單元的加權平均授予日期公允價值分別爲 $10。5.7萬美元和19.1 2024年9月30日結束的三個月和九個月分別爲美元的所得稅費用,相比之下,2019年12月31日結束的三個月和九個月的所得稅費用爲美元。5.0萬美元和13.0 2019年12月31日結束的三個月和九個月的所得稅費用分別爲美元,與2023年相應期間相比,2024年9月30日結束的三個月和九個月的增加主要是由於稅前賬面收入增加。
我們的有效稅率與聯邦法定稅率不同,這是因爲州所得稅以及我們股權補償中不可抵扣部分的存在,導致我們的稅收支出增加,但又被研發積分和員工期權行使所得的超額稅收減免抵消,從而減少我們的應稅收入。
截至2024年9月30日止三個月和九個月,未確認的稅務優惠增加了$1.3萬美元和3.42024年4月30日和2023年4月30日的六個月內的外匯重新計量淨收益分別爲$百萬。
每個季度我們評估我們將產生足夠應稅所得以使用聯邦和州遞延稅款資產的可能性。除了抵銷我們加利福尼亞州淨遞延稅款資產價值的減值準備金之外,我們已經確定我們很可能會實現與所有其他遞延稅款資產相關的利益。在我們增加減值準備金的範圍內,我們將在做出這種決定的期間在簡明綜合收入表中包括一項費用。
自2022年開始,2017年的稅收削減和就業法案取消了抵扣研發支出的權利,而是要求所有美國和外國的研發支出分別在五年和十五年的稅務年限內攤銷。國會曾考慮過推遲攤銷要求至以後年份的立法,但截至2024年9月30日,該要求尚未修改。
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項目2.財務狀況和經營成果的管理討論與分析
下文經營管理討論和基本報表條件及業績分析(「MD&A」)旨在幫助讀者了解我們的業務運營結果和財務狀況,並作爲我們簡明的合併財務基本報表、基本報表附註、風險因素和其他披露的補充,請與本10-Q表格中包括的內容一起閱讀。我們的簡明合併財務基本報表已按照美國通用會計準則(「U.S. GAAP」)編制。
我們在本節中做出的聲明屬於聯邦證券法的「前瞻性聲明」。要全面討論這些聲明以及可能影響其準確性的潛在風險和不確定性,請參閱本10-Q表格的「風險因素」部分以及本MD&A的「概述」和「流動性和資本資源」部分。
概述
我們是一家商業階段公司,致力於發現和開發藥物,用於治療嚴重的內分泌、腫瘤、代謝和神經疾病,通過調節激素皮質醇的作用。自2012年以來,我們推出了Korlym®,用於治療患有庫欣綜合症的患者。在2024年6月,我們推出了Korlym的授權仿製藥版本,用於相同適應症。我們的專有選擇性皮質醇調節劑組合包括四個在結構上不同的系列,總共超過1,000種化合物。
庫欣綜合徵
Korlym。 我們在美國銷售Korlym和一個Korlym的仿製版本,利用銷售代表拜訪爲患有高皮質醇症(庫欣氏綜合徵)的患者提供照護的醫生。我們還有一支基於現場的醫學科學聯絡官隊伍。我們利用專業藥房和專業經銷商分發我們的藥物,併爲醫生和患者提供後勤支持。我們的政策是,不會因爲財務原因而拒絕爲有庫欣氏綜合徵的患者提供我們的藥物。爲了幫助我們實現這一目標,我們設立了患者支持計劃,並向獨立的慈善基金會捐款,幫助患者支付庫欣氏綜合徵治療的所有方面,無論是否包括服用我們的藥物。
由於大多數患有庫欣綜合症的人未經正確診斷或治療,我們制定並不斷完善和擴展計劃,旨在教育醫生和患者進行高皮質醇血癥篩查,並介紹 Korlym 在治療患有該疾病的患者中的作用。我們正在進行一項研究(「CATALYST」),旨在判斷患有難以控制的糖尿病(即 HbA1c 高於7.5%)的患者中庫欣綜合症的患病率。在首階段的 CATALYST 中,共有1,055名患者入組,其中發現24%的患者患有高皮質醇血癥。這些患者有機會參加 CATALYST 的第二階段,符合條件的患者將以2:1的比例隨機分配接受 Korlym 或安慰劑治療24周。我們期望來自 CATALYST 的患病率和治療數據能幫助醫生更好地識別患有庫欣綜合症的患者,並確定他們的最佳治療方案。
Relacorilant。 我們正在開發我們專有的、選擇性的皮質醇調節劑Relacorilant,作爲庫欣氏綜合症患者的治療。 Relacorilant與Korlym對糖皮質激素受體(GR)的親和性相似,但與Korlym不同,不具有孕激素受體(PR)的親和性,因此不是「流產藥丸」,也不會引起與PR親和性有關的其他效應,包括子宮內膜增厚和陰道出血。由於Relacorilant也不會顯著增加皮質醇水平,因此不會導致低鉀血癥(低鉀),這是患者停止使用Korlym治療的主要原因之一。Korlym的關鍵試驗中,44%的患者出現低鉀血癥。與用於治療庫欣氏綜合症的所有其他藥物不同,Relacorilant不會延長心臟的QT間期,這是一種可能致命的非靶效應。
我們已經完成了relacorilant在Cushing綜合症患者中的兩項3期試驗-我們的關鍵試驗「GRACE」和我們的「GRADIENT」試驗。在這兩項試驗中,患者表現出高血壓、血糖控制、體重和體成分以及其他Cushing綜合症體徵和症狀方面具有臨床意義的改善。Relacorilant的耐受性良好。值得注意的是,患者沒有經歷Korlym或其他目前批准治療中可能出現的一些嚴重不良事件。
GRACE試驗分爲兩部分。首先是開放標籤階段,招募了152名任何患有庫欣氏綜合徵病因的患者。每位患者接受relacorilant治療22周。表現出預先規定改善的高血壓、高血糖或兩種症狀中任何一種的患者,繼續進行GRACE的第二個,雙盲,隨機撤回階段,其中一半的患者繼續接受relacorilant,另一半接受安慰劑治療12周。GRACE的主要終點是繼續接受relacorilant治療的患者失去血壓控制,與將relacorilant替換爲安慰劑的患者進行比較。
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在開放標籤階段,患者在廣泛的庫欣綜合徵體徵和症狀方面經歷了臨床意義和統計學顯著的改善,包括高血壓、高血糖、體重、腰圍、脂肪和瘦體重、認知和庫欣生活質量評分。
所有高血壓患者的收縮壓(SBP)和舒張壓(DBP)均有快速且持續的改善,22周時平均SBP改善了7.9毫米汞柱,平均DBP改善了5.4毫米汞柱(p值:<0.0001)。在開放標籤階段,63%的高血壓患者符合研究的響應標準。進入隨機退出階段的患者中,高血壓症狀的改善甚至更爲顯著,22周時平均SBP改善了12.6毫米汞柱,平均DBP改善了8.3毫米汞柱(p值:<0.0001)。爲確保準確性,高血壓是通過24小時動態血壓監測(ABPM)來測量的。
葡萄糖代謝通過多個診斷測試進行測量,包括口服葡萄糖耐量試驗(葡萄糖曲線下面積或AUC葡萄糖),糖化血紅蛋白(HbA1c)和空腹血糖。對於所有患有糖尿病和受損葡萄糖耐量(即糖尿病前期)的患者,葡萄糖代謝均有臨床意義和統計顯著改善。數據顯示22周時AUC葡萄糖均值改善了3.3 h*mmol/L,HbA1c均值改善了0.3%,空腹血糖均值改善了12.4 mg/dL(分別爲p值:<0.0001,0.03,0.03)。在開放標籤階段,50%的高血糖患者符合研究的反應標準。進入隨機撤退階段的患者,高血糖的改善更爲顯著,22周時AUC葡萄糖均值改善了6.2 h*mmol/L,HbA1c均值改善了0.7%,空腹血糖均值改善了25.2 mg/dL(分別爲p值:<0.0001,<0.0001,0.006)。
格雷斯在隨機撤回階段達到了血壓控制喪失的主要終點,與被轉換到安慰劑的患者相比,繼續接受雷拉考瑞的患者的結果(比值比:0.17;p值:0.02)。繼續接受雷拉考瑞的患者也保持了他們在高血糖、腰圍和脂肪和瘦體重方面的改善。接受安慰劑的患者經歷了腎上腺皮質功能亢進綜合徵體徵和症狀的明顯惡化。
我們的第3階段GRADIENt研究支持GRACE試驗,進一步證明了relacorilant的有效性和安全性。GRADIENt研究了由腎上腺腺瘤或腎上腺增生引起的庫欣綜合症患者。這些患者通常表現出較輕的症狀,並且比其他庫欣綜合症病因的患者有更漸進的下降,儘管他們的健康結局最終是糟糕的。GRADIENt招募了137名患有庫欣綜合症且患有高血壓、高血糖或兩者的患者。患者以雙盲方式以1:1隨機分配,分別接受relacorilant或安慰劑治療22周。試驗的主要終點是與安慰劑相比改善收縮壓並控制血糖,體重和體脂含量作爲次要終點。
在接受relacorilant治療的GRADIENt患者中,與基線相比,高血壓、高血糖、體重和體成分方面表現出臨床意義和統計學上顯著的改善,而接受安慰劑治療的患者則沒有。
接受relacorilant治療的高血壓患者,平均收縮壓下降了6.6毫米汞柱(p值0.012),與基線相比。接受安慰劑的患者收縮壓下降了2.1毫米汞柱(p值:ns),與基線相比。接受relacorilant和安慰劑的患者之間的比較在統計學上沒有顯著差異。在研究期間,5名接受安慰劑治療的患者需要抗高血壓藥物的搶救治療,而只有1名接受relacorilant治療的患者需要。爲確保準確性,高血壓是通過24小時動態監測血壓來測量的。
接受relacorilant治療的高血糖患者在葡萄糖代謝方面經歷了臨床意義重大且統計學上顯著的改善,包括空腹血糖(與安慰劑相比減少了22.2 mg/dL;p值0.002)、口服葡萄糖耐量試驗下曲線面積(與安慰劑相比減少了2.6 h*mmol/L;p值0.046)和A1c血紅蛋白(與安慰劑相比減少了0.3個百分點;p值0.019)。
在GRADIENt接受relacorilant治療的患者,體重和內臟脂肪質量和成交量均顯著改善(相比接受安慰劑的患者,體重減輕了3.9公斤,p值爲0.0001;內臟脂肪質量和成交量的p值分別爲0.018和0.016)。
Relacorilant在GRADIENt中耐受性良好,副作用與其在第2期和GRACE試驗中觀察到的一致。在所有這些研究中,最常見的不良事件包括輕至中度噁心、水腫、四肢和背部疼痛以及疲勞 - 所有這些症狀都與很多患者在手術後或開始治療庫欣氏綜合徵的過程中經歷的「皮質醇戒斷」有關。重要的是,在這些實例中沒有出現由relacorilant引起的低鉀血癥、子宮內膜增生或相關的陰道出血、腎上腺功能不全或QT間期延長。
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美國食品藥品監督管理局(「FDA」)和歐盟委員會(「EC」)已將relacorilant指定爲庫欣徵兆的孤兒藥物。在美國,relacorilant的孤兒藥物指定將獲得稅收抵免、減少監管費用,並且如果我們獲得庫欣徵兆治療的批准,將獲得七年的獨家營銷權利。歐盟的孤兒藥物指定也帶來類似的好處,但還包括歐洲藥品管理局(「EMA」)的協議援助、在歐盟獲得專門營銷授權程序的准入,以及如果我們獲得批准,將獲得在歐盟爲庫欣徵兆患者治療的十年獨家營銷權利。
腫瘤學
有充分證據表明,在某些抗癌療法中,皮質醇在G蛋白偶聯受體上的活性會降低效力,並且調節皮質醇的活性可能有助於抗癌治療實現預期效果。在某些癌症中,皮質醇抑制細胞凋亡 - 很多治療方案旨在刺激的殺傷腫瘤效應。而在其他癌症中,皮質醇的活性促進腫瘤生長。皮質醇還會抑制人體的免疫反應;激活 - 而不是抑制 - 免疫系統有助於對抗某些癌症。許多實體瘤表達G蛋白偶聯受體,並且是皮質醇調節療法的潛在靶點,其中包括卵巢癌、腎上腺癌和前列腺癌。
鉑金耐藥性卵巢癌患者中的Relacorilant。 我們正在進行一個關鍵的3期試驗(「ROSELLA」),使用我們的專有、選擇性皮質醇調節劑Relacorilant與nab-紫杉醇聯合治療鉑金耐藥性卵巢癌患者。ROSELLA的入組已經結束。381名有複發性、鉑金耐藥性卵巢癌的婦女被隨機分爲1:1,分別接收間斷150毫克的Relacorilant和nab-紫杉醇或者nab-紫杉醇單藥治療。ROSELLA的主要終點是無進展生存期(「PFS」),整體生存期是一個關鍵的次要終點。參加ROSELLA的患者需要接受過先前的Bevacizumab治療,這是治療鉑金耐藥性卵巢癌患者的已批准標準療法。患有對最初的鉑金類藥物治療無反應的腫瘤史(即患有「初次鉑金耐藥性」疾病的婦女)以及接受過三條以上治療線的婦女被排除在外。
ROSELLA旨在複製我們的2期試驗的積極結果,這是一項治療鉑金耐藥性卵巢癌患者的178例受控多中心試驗,包括relacorilant與nab-紫杉醇聯合治療。2期研究參與者被隨機分配到三種治療組中的一組:60名女性間斷性地接受150毫克relacorilant(在每週接受nab-紫杉醇治療的前一天、當天和第二天);58名女性每天額外服用100毫克的relacorilant,同時接受nab-紫杉醇治療;60名女性僅接受nab-紫杉醇治療。試驗的主要終點是無進展生存期(PFS)。
在2期試驗的relacorilant加nab-紫杉醇治療組中,患者的無進展生存期(PFS)比單獨接受nab-紫杉醇的患者更長。間歇性接受更高劑量relacorilant的患者在中位PFS上表現出明顯改善(5.6個月對比3.8個月,風險比:0.66;p值:0.038)。每日接受較低劑量relacorilant的患者顯示出比單獨接受nab-紫杉醇的患者更長的中位PFS(5.3個月對比3.8個月,風險比:0.83;p值:無顯著差異)。間歇性接受relacorilant的患者還具有比單獨接受nab-紫杉醇的患者更長的反應持續時間(DoR)(5.6個月對比3.7個月,風險比:0.36;p值:0.006)。間歇性接受relacorilant的患者也活得更久(中位總生存期:13.9個月對比12.2個月,風險比:0.67;p值:0.066)。
在第2期試驗中,將relacorilant添加到nab-紫杉醇治療中,並未爲患者帶來額外的不良事件負擔。 relacorilant加nab-紫杉醇的安全性和耐受性與nab-紫杉醇單藥療法相當。
我們第二階段試驗的最終分析已發表在 《臨床腫瘤學雜誌》2022年第40卷21期2321-2332頁: Burtness億.等。 《關鍵點048中的Pembrolizumab單藥或聯合化療用於復發/轉移性頭頸鱗狀細胞癌:通過編程死亡配體1合併陽性評分的亞組分析》。請注意,5.4%的ORR和32.4%的DCR是根據具有CPS的37位可評估患者計算得出的 (Colombo等,2023),美國臨床腫瘤學會(ASCO)的重要期刊。
Relacorilant在有皮質醇過多的腎上腺癌患者中的應用。 我們已經完成了一個開放標籤的Phase 10億試驗,試驗中包括了14位轉移性或不可切除的腎上腺癌患者,這些患者的腫瘤會產生皮質醇。患有這種形式的腎上腺癌的患者幾乎不會對免疫療法產生響應,腫瘤的進展非常迅速。我們的試驗旨在檢驗在pembrolizumab療法中添加relacorilant是否足以減少皮質醇激活的免疫抑制,以幫助患者的免疫系統減少或清除患者的腫瘤,同時減輕腫瘤過度產生皮質醇引起的庫欣氏綜合徵症狀。 雖然我們試驗中的患者症狀,如高血壓和高血糖,有顯著改善,但腫瘤的進展並沒有放緩。relacorilant與pembrolizumab的組合耐受性良好。我們正在評估下一步措施,以進一步了解皮質醇調節與免疫療法在其他腫瘤類型和早期癌症階段中的作用。
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前列腺癌患者中的Relacorilant去勢療法是前列腺癌的標準治療,因爲雄激素刺激前列腺腫瘤生長。皮質醇也會刺激前列腺腫瘤生長,皮質醇在糖皮質激素受體處的作用可能導致腫瘤逃脫雄激素剝奪療法。將皮質醇調節劑與雄激素調節劑結合可能阻斷這一逃逸路徑。我們在芝加哥大學的合作伙伴已經開始了在前列腺癌患者,術前的前列腺切除患者中對Relacorilant和Enzalutamide進行隨機、安慰劑對照的2期試驗。我們爲研究提供了Relacorilant和安慰劑。 我們從芝加哥大學獲得的專利涵蓋了使用Relacorilant與抗癌藥物,包括Enzalutamide,用於治療具有這一適應症的患者。
肌萎縮側索硬化(「ALS」)
ALS,又稱爲路易·格里格病,是一種毀滅性的神經肌肉疾病。我們的選擇性皮質醇調節劑達祖考利昔在ALS動物模型中改善了運動表現,並減少了神經炎症和肌肉萎縮。在這些令人信服的結果之後,我們啓動了達祖考利昔在ALS患者中的2期試驗(「DAZALS」)。249名患者進行了隨機分組,以雙盲方式1:1:1接受每天150毫克達祖考利昔、300毫克達祖考利昔或安慰劑治療24周。DAZALS的主要終點是ALS功能評定量表-修訂版(ALSFRS-R)在接受達祖考利昔和接受安慰劑治療的患者之間的差異。招募工作已完成。FDA已將達祖考利昔指定爲美國ALS治療的孤兒藥品。
代謝性疾病
肝病。 代脂肝疾病(MASH)是代謝紊亂相關脂肪肝病的一種愛文思控股形式,困擾着數百萬患者,是與肝臟有關的死亡的主要原因。我公司愛文思控股試驗階段的選擇性皮質醇調節劑米力可瑞蘭作爲一種治療MASH潛在藥物的試診確定了一種劑量方案,可以減少肝脂肪,改善肝臟健康和主要代謝和脂質指標,而且耐受良好。在取得這些觸目驚心的結果後,我們於2023年10月開始了隨機、雙盲、安慰劑對照的第20億階段試驗(「MONARCH」),以檢查米力可瑞蘭在患有MASH的患者中的效果。MONARCH有兩個患者隊列。A隊列計劃招募120名經活檢確認患有MASH的患者,隨機分組爲2:1,分別接受每週兩次100毫克的米力可瑞蘭或安慰劑治療48周。A隊列的主要終點是減少肝脂肪,而MASH緩解和纖維化改善爲關鍵次要終點。B隊列計劃招募75名被推斷爲患有MASH的患者,隨機分組爲2:1,分別接受每週兩次100毫克的米力可瑞蘭治療6周,然後每週兩次200毫克的米力可瑞蘭治療18周,或安慰劑治療24周。B隊列的主要終點是減少肝脂肪。
抗精神病藥物引起的體重增加(「AIWG」). 在美國,有600萬人正在服用抗精神病藥物,如奧氮平和利培酮,用來治療精神分裂症、躁鬱症和抑鬱症等疾病。雖然這些藥物非常有效,但它們常常會引起迅速和持續的體重增加,其他代謝紊亂,最終甚至導致心血管疾病。我們在服用抗精神病藥物後體重增加的患者中進行了兩項miricorilant的2期試驗。然而,在這些研究中,接受miricorilant的患者並沒有減輕體重。2023年10月,我們開始了一項第1期試驗,研究miricorilant預防AIWG的潛力,但由於缺乏功效,我們於2024年6月終止了該試驗。
藥物發現和臨床前開發
我們繼續從我們的選擇性皮質醇調節劑組合中鑑定新化合物,並推進其中最有前景的化合物進入臨床階段。
2022年通脹縮減法
2022年8月16日,通貨膨脹減緩法案(IRA)被頒佈。IRA包括規定,如果Medicare b部分或D部分藥品的價格上漲速度超過通貨膨脹率,製造商需要向醫療保險與醫療補助中心(CMS)支付回扣。此外,從2025年開始,IRA還將把目前由政府和受益人分擔的醫療保險受益人成本的重要部分轉移到製造商身上。我們預計這一規定將極大限制我們從Medicare患者處獲得的營業收入,並可能在很大程度上減少我們的利潤。IRA允許CMS就某些高支出的Medicare b部分或D部分藥品進行價格談判。
IRA還對某些股票回購徵收1%的消費稅,並對調整後的基本報表收入引入15%的企業備選最低稅。企業備選最低稅於2024年1月1日對我們生效。我們不預計這兩項規定會對我們的綜合財務報表產生重大影響。
請查看本季度10-Q表格中第1A條款下的風險因素。 新的法律、政府法規或對現行法律和法規的更改可能會使我們難以獲得可接受的價格或足夠的
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保險覆蓋和藥物報銷,可能對我們的運營結果和財務狀況產生不利影響.”
經營結果
淨產品營業收入 淨產品收入是指銷售給我們客戶的總產品收入,扣除了預計政府折扣和退款、患者醫療費用援助項目、提供給我們專業分銷商以獲得及時付款的折扣以及預期退貨準備金。
產品淨收入分別爲2024年9月30日結束的三個月和九個月的收入爲18250萬美元和49320萬美元,而2023年同期分別爲12360萬美元和34700萬美元。更高的銷售量分別佔2024年9月30日結束的三個月和九個月的增長的89.0%和78.6%,其餘增長歸因於 於2024年1月1日生效的價格上漲。
銷售成本 銷售成本包括原料藥(API)、製片、包裝、人員、製造費用、穩定性測試和分銷成本。
銷售成本分別爲2024年9月30日結束的三個月和九個月分別爲290萬和790萬美元,而在2023年相應期間分別爲160萬和460萬美元。銷售成本與營業收入的比例分別爲2024年9月30日結束的三個月和九個月均爲1.6%,而在2023年相應期間則均爲1.3%。這些增加主要是由於製造業、運輸和分銷成本的增加。
研發費用研發費用包括(1)臨床試驗的費用,(2)招募和補償開發人員的費用,(3)製造研究性藥物產品的費用,(4)臨床前研究的費用,(5)藥物發現研究的費用和(6)新藥劑型和製造工藝的研發費用。
截至2024年9月30日的三個月和九個月,研發費用分別爲5930萬美元和17660萬美元,而2023年同期分別爲4550萬美元和12960萬美元。這些增加是因爲在推進和完成我們的開發項目以及增加員工薪酬方面的支出增加。
截至9月30日的三個月截至9月30日的九個月
 2024202320242023
(以千爲單位)
臨床開發計劃:  
腫瘤學$13,007 $11,493 $42,237 $27,925 
庫欣綜合症14,273 8,980 39,930 27,747 
代謝性疾病10,406 8,122 29,914 24,597 
臨床前和早期選擇性皮質醇調節劑9,583 7,871 30,028 23,594 
未分配的活動,包括製造業-半導體和監管活動7,407 5,028 21,460 14,614 
以股票爲基礎的報酬計劃4,660 4,023 13,018 11,169 
總研發費用$59,336 $45,517 $176,587 $129,646 
預測開發活動的時間和費用是困難的,存在許多不確定性和風險,包括結論不明確或爲負面結果、患者入組緩慢、不良副作用以及研究藥物的配方或製造困難和候選藥物功效不足。此外,臨床開發受到政府監督和可能會在未經通知的情況下改變的法規約束。隨着我們的臨床項目推進,我們預計2024年的研發支出將高於2023年。未來幾年的研發支出將取決於我們的臨床試驗和開發計劃的結果。
銷售、一般和行政費用 銷售、一般和行政費用包括(1)從事商務和行政活動的僱員、顧問和承包商的薪酬,(2)支持商務活動的供應商成本和(3)法律和會計費用。
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Selling, general and administrative expense was $73.7 million and $196.9 million for the three and nine months ended September 30, 2024, respectively, compared to $45.3 million and $137.1 million for the comparable periods in 2023. The increases were primarily due to increased employee compensation expenses and sales and marketing activities.
We expect our selling, general and administrative expense to be higher in 2024 than in 2023 due to increased commercial and administrative activities, including litigation and administrative support for increased research and development and marketing efforts.
Interest and other income - Interest and other income was $6.3 million and $17.8 million for the three and nine months ended September 30, 2024, respectively, compared to $5.2 million and $12.1 million for the comparable periods in 2023. The increases were due to higher cash and investment balances and market-wide increases in interest rates.
Income tax expense - Income tax expense was $5.7 million and $19.1 million for the three and nine months ended September 30, 2024, respectively, compared to income tax expense of $5.0 million and $13.0 million for the comparable periods in 2023. The increases were primarily due to increased pretax book income.
Liquidity and Capital Resources
We rely on revenues from the sale of our medications to fund our operations.
Based on our current plans and expectations, we expect to fund our operations and planned research and development activities over the next 12 months and beyond without needing to raise additional funds, although we may choose to raise additional funds for other reasons. If we were to raise funds, equity financing would be dilutive, debt financing could involve restrictive covenants and funds raised through collaborations with other companies may require us to relinquish certain rights in our product candidates.
As of September 30, 2024, we had cash, cash equivalents and marketable securities of $547.6 million, consisting of cash and cash equivalents of $137.3 million and marketable securities of $410.4 million, compared to cash, cash equivalents and marketable securities of $425.4 million, consisting of cash and cash equivalents of $135.6 million and marketable securities of $289.8 million as of December 31, 2023.
The cash in our bank accounts and our marketable securities could be reduced or our access to them restricted if the financial institutions holding them were to fail or severely adverse conditions were to arise in the markets for public or private debt securities. We have never experienced a material lack of access to cash or material realized losses.
Net cash provided by operating activities was $138.8 million for the nine months ended September 30, 2024, compared to $121.2 million for the comparable period in 2023. The increase was primarily due to higher revenue.
Net cash used in investing activities was $113.2 million for the nine months ended September 30, 2024, compared to net cash provided by investing activities of $73.8 million for the comparable period in 2023. The change was primarily due to allocation of cash proceeds from maturities of marketable securities towards cash equivalents in anticipation of the closing of our tender offer during the comparable period in 2023.
Net cash used in financing activities was $23.8 million for the nine months ended September 30, 2024, compared to $149.5 million for the comparable period in 2023. In the nine months ended September 30, 2024, we spent $31.0 million acquiring shares of our common stock, comprised of $15.7 million pursuant to our Stock Repurchase Program, $12.2 million acquiring shares of our common stock in connection with the net exercise of employee and director stock options, and $3.1 million to satisfy tax withholding requirements from vesting of restricted stock grants, offset by $3.9 million received in connection with our ESPP and $3.3 million net cash received from the exercise of stock options. In the comparable period in 2023, we spent $153.5 million acquiring shares of our common stock, comprised of $145.4 million pursuant to our tender offer, $6.8 million acquiring shares of our common stock in connection with the net exercise of employee and director stock options and $1.3 million to satisfy tax withholding requirements from vesting of restricted stock grants, offset by $3.0 million received in connection with our ESPP and $1.1 million net cash received from the exercise of stock options.
As of September 30, 2024, we had retained earnings of $513.0 million.
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Contractual Obligations and Commitments
Our contractual payment obligations and purchase commitments are disclosed in our Annual Report on Form 10-K for the year ended December 31, 2023. Other than future minimum lease payments with respect to our sublease for office space with Zuora, our payment obligations and purchase commitments did not change materially during the nine months ended September 30, 2024. See Notes 4 and 5 to our Unaudited Condensed Consolidated Financial Statements for more information regarding our purchase commitments and future minimum lease payments, respectively.
Critical Accounting Policies and Estimates
Our condensed consolidated financial statements have been prepared in accordance with U.S. GAAP, which requires us to make estimates and judgments that affect the amount of assets, liabilities and expenses we report. We base our estimates on historical experience and on other assumptions we believe to be reasonable. Actual results may differ from our estimates. Our significant accounting policies are described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023. There were no changes that occurred during the fiscal quarter covered by this report that materially affected, or are reasonably likely to materially affect, our critical accounting policies and estimates.
ITEM 3.  QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Our market risks as of September 30, 2024 are disclosed in our Annual Report on Form 10-K for the year ended December 31, 2023. The market risks associated with our cash, cash equivalents and marketable securities, which consist entirely of debt instruments with original maturities of less than 26 months did not change materially during the nine months ended September 30, 2024.
ITEM 4.  CONTROLS AND PROCEDURES
Evaluation of disclosure controls and procedures. As of September 30, 2024, our management conducted an evaluation, under the supervision and with the participation of our Chief Executive Officer and Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934 (the “Exchange Act”). Based upon that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that, as of September 30, 2024, our disclosure controls and procedures were effective to provide reasonable assurance that the information required to be disclosed by the Company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in SEC rules and forms and that such information is accumulated and communicated to the officers who certify our financial reports and to the members of the Company’s senior management and board of directors as appropriate to allow timely decisions regarding required disclosure at the reasonable assurance level.
Changes in internal control over financial reporting. Our Chief Financial Officer and other members of management evaluated the changes in our internal control over financial reporting during the quarter ended September 30, 2024 and concluded that there was no change during the quarter that materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
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PART II. OTHER INFORMATION
ITEM 1.  LEGAL PROCEEDINGS
Teva Patent Litigation
In February 2018, we received a Paragraph IV Notice Letter advising that Teva Pharmaceuticals USA, Inc. (“Teva”) had submitted an Abbreviated New Drug Application (“ANDA”) to the FDA seeking authorization to manufacture and sell a generic version of Korlym prior to the expiration of patents related to Korlym that are listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”). In March 2018, we filed a lawsuit in the United States District Court for the District of New Jersey (“D.N.J.”) against Teva for infringement of our patents. In August 2020, Teva received final approval from the FDA for its ANDA in accordance with the Hatch-Waxman Act.
In May 2019, Teva submitted to the Patent Trial and Appeal Board (“PTAB”) a petition for post-grant review (“PGR”) of U.S. Patent No. 10,195,214 (the “’214 patent”). In November 2020, the PTAB issued a decision upholding the validity of the ’214 patent in its entirety, which decision the Federal Circuit Court of Appeals upheld. This matter is closed.
The patents currently at issue in the D.N.J matter are the ʼ214 patent and U.S. Patent No. 10,842,800 (the “’800 patent”). Trial was held from September 26, 2023 through September 28, 2023 before Judge Renee Marie Bumb. On December 29, 2023, Judge Bumb ruled that Teva’s proposed generic product would not infringe either the ’214 or ’800 patent. We have appealed that ruling to the United States Court of Appeals for the Federal Circuit. Teva launched its generic product in January 2024.
We will vigorously enforce our intellectual property rights relating to Korlym but cannot predict the outcome of these matters.
Teva Antitrust Litigation
On June 13, 2024, Teva filed a complaint in the Northern District of California, captioned Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc., et al. (N.D. Cal.), Case No. 3:24-cv-03567-BLF (the “Teva Antitrust Litigation”). This lawsuit names Corcept and Optime Care, Inc. (“Optime”), our single specialty pharmacy that dispenses Korlym and performs related pharmacy and patient support services, as defendants and alleges, among other things, that Corcept has violated federal and state laws related to antitrust and unfair business practices. On August 26, 2024, Corcept and Optime filed motions to dismiss the complaint. On September 13, 2024, Teva filed a First Amended Complaint, and on October 14, 2024, Corcept and Optime moved to dismiss the First Amended Complaint. A hearing on the motion to dismiss has been scheduled for February 20, 2025.
Other Litigation
In March 2019, a purported securities class action complaint was filed in the United States District Court for the Northern District of California by Nicholas Melucci (Melucci v. Corcept Therapeutics Incorporated, et al., Case No. 5:19-cv-01372-LHK) (the “Melucci litigation”). The complaint named us and certain of our executive officers as defendants asserting violations of Sections 10(b) and 20(a) of the Exchange Act and Rule 10b-5 promulgated thereunder and alleged that the defendants made false and materially misleading statements and failed to disclose adverse facts about our business, operations and prospects. The complaint asserted a putative class period extending from August 2, 2017 to February 5, 2019 and sought unspecified monetary relief, interest and attorneys’ fees. On June 6, 2024, Judge James Donato of the United States District Court for the Northern District of California granted final approval of a settlement resolving all claims in the Melucci litigation (the “Melucci Settlement”). As previously disclosed, the Melucci Settlement required us to make a one-time payment of $14 million for which our insurers reimbursed us in full. On September 6, 2024, Judge Donato approved the Plan of Allocation for payment of the settlement funds to eligible members of the class of plaintiffs. This matter is closed.
In September 2019, a purported shareholder derivative complaint was filed in the United States District Court for the District of Delaware by Lauren Williams, captioned Lauren Williams v. G. Leonard Baker, et al., Civil Action No. 1:19-cv-01830. A second nearly identical lawsuit was filed in December 2019 in the United States District Court for the District of Delaware by Jeweltex Pension Plan, captioned Jeweltex Pension Plan v. James N. Wilson, et al., Civil Action No. 1:19-cv-02308. These complaints named the then-existing members of our board of directors, our Chief Executive Officer and our current Chief Business Officer as defendants, and Corcept as a nominal defendant. The complaints allege breach of fiduciary duty, violation of Section 14(a) of the Exchange Act, insider selling, misappropriation of insider information and waste of corporate assets and seek damages in an amount to be proved at trial. These actions had been stayed pending resolution of the Melucci litigation. On June 21, 2024, the United States District Court for the District of Delaware lifted the stays on the Williams and Jeweltex cases and consolidated these two cases into one case.
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In January 2022, a purported shareholder derivative complaint was filed in the Delaware Court of Chancery by Joel B. Ritchie, captioned Joel B. Ritchie v. G. Leonard Baker, et al., Case No. 2022-0102-SG. The complaint named certain members of our Board of Directors, our Chief Executive Officer, our current Chief Business Officer and our President of Corcept Endocrinology as defendants, and Corcept as nominal defendant. The complaint alleges a single cause of action for breach of fiduciary duty. The complaint seeks damages in an amount to be proved at trial. On March 22, 2024, the Court lifted a previously-entered stay, which had been pending the resolution of the Melucci litigation, and on May 3, 2024, we filed a Motion to Dismiss this complaint. We cannot predict when the Court will rule on this motion.
Given the overlapping allegations in these shareholder derivative actions, we and the individual defendants have filed a One Forum Motion in both the United States District Court for the District of Delaware and the Delaware Court of Chancery requesting that the Courts coordinate to determine in which jurisdiction (Federal or Chancery Court) these matters should first proceed. The Courts have not yet ruled on that Motion.
We will respond vigorously to the above allegations but cannot predict the outcome of these matters.
Records Subpoena
In November 2021, we received a records subpoena from the United States Attorney’s Office for the District of New Jersey (the “NJ USAO”) pursuant to Section 248 of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) seeking information relating to the sale and promotion of Korlym, our relationships with and payments to health care professionals who can prescribe or recommend Korlym and prior authorizations and reimbursement for Korlym. The NJ USAO has informed us that it is investigating whether any criminal or civil violations by us occurred in connection with the matters referenced in the subpoena. It has also informed us that it does not currently consider us a defendant but rather an entity whose conduct is within the scope of the government’s investigation.
In addition to the above-described matters, we are involved from time-to-time in other legal proceedings arising in the ordinary course of our business. Although the outcome of any such matters and the amount, if any, of our liability with respect to them cannot be predicted with certainty, we do not believe that they will have a material adverse effect on our business, results of operations or financial position.
ITEM 1A.  RISK FACTORS
Investing in our common stock involves significant risks. Before investing, carefully consider the risks described below and the other information in this quarterly report, including our condensed consolidated financial statements and related notes. The risks and uncertainties described below are the ones we believe may materially affect us. There may be others of which we are unaware that could materially harm our business or financial condition and cause the price of our stock to decline, in which case you could lose all or part of your investment.
Summary of Principal Risks
The following bullet points summarize the principal risks we face, each of which could adversely affect our business, operations and financial results. Below, we have arranged these risks by the part of our business they most directly affect.
Risks Related to our Commercial Activities
Failure to generate sufficient revenue from the sale of Korlym would harm our financial results and would likely cause our stock price to decline.
The availability of generic Korlym could adversely affect our business, results of operations and financial position.
Public perception of mifepristone or legislation limiting or barring its use for termination of early pregnancy may limit our ability to sell our medications.
New laws, government regulations, or changes to existing laws and regulations could make it difficult or impossible for us to obtain acceptable prices or adequate insurance coverage and reimbursement for Korlym, which would adversely affect our results of operations and financial position.
Risks Related to our Research and Development Activities
Vendors perform many of the activities necessary to carry out our clinical trials, including drug product distribution, trial management and oversight and data collection and analysis. Failure of these vendors to perform their duties or meet expected timelines may prevent or delay approval of our product candidates.
Our efforts to discover, develop and commercialize our product candidates may not succeed. Clinical drug development is lengthy, expensive and often unsuccessful. Results of early studies and trials are often not predictive of
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later trial results. Failure can occur at any time. Even if we deem that our product candidates’ clinical trial results demonstrate safety and efficacy, regulatory authorities may not agree. Failure to obtain or maintain regulatory approvals for our product candidates would prevent us from commercializing them.

Risks Relating to our Intellectual Property
To succeed, we must secure, maintain and effectively assert adequate patent protection for the composition and methods of use of our proprietary, selective cortisol modulators and for the use of Korlym to treat Cushing’s syndrome. Litigation is slow and expensive and its outcome is uncertain and subject to challenge on appeal.
Risks Related to our Stock
The price of our common stock fluctuates widely and is likely to continue to do so. Opportunities for investors to sell shares may be limited.
Our stock price may decline if our financial performance does not meet the guidance we have provided to the public, estimates published by research analysts or other investor expectations.
General Risk Factors
We rely on information technology to conduct our business. A breakdown or breach of our information technology systems or our failure to protect confidential information concerning our business, patients or employees could interrupt the operation of our business and subject us to liability.
Risk Factors – Discussion
The following section discusses the principal risks listed above, as well as other risks we believe to be material.
Risks Related to our Commercial Activities
Failure to generate sufficient revenue from the sale of Korlym would harm our financial results and would likely cause our stock price to decline.
Our ability to generate revenue and to fund our commercial operations and development programs is dependent on the sale of Korlym to treat patients with Cushing’s syndrome. Physicians will prescribe Korlym if they determine that it is preferable to other treatments, even if those treatments are not approved for Cushing’s syndrome. Most physicians are inexperienced diagnosing or caring for patients with Cushing’s syndrome and it can be hard to persuade them to identify appropriate patients and treat them with Korlym.
Many factors could limit our Korlym revenue, including:
the preference of physicians or payors for competing treatments for Cushing’s syndrome, including a lower-priced generic version of Korlym and off-label treatments; and
lack of availability of government or private insurance, the shift of a significant number of patients to Medicaid, which reimburses Korlym at a significantly lower price, or the introduction of government price controls or other price-reducing regulations, such as the Inflation Reduction Act of 2022, that may significantly limit Medicare reimbursement rates.
Failure to generate sufficient Korlym revenue could prevent us from fully funding our planned commercial and clinical activities and would likely cause our stock price to decline.
The availability of generic Korlym could adversely affect our business, results of operations and financial position.
In January 2024, Teva launched a generic version of Korlym. We have sued Teva in Federal District Court with respect to its generic version of Korlym. On December 29, 2023, the Court issued a ruling in that case finding that Teva’s generic product would not infringe the patents we have asserted against it. We have appealed this adverse decision to the Federal Circuit Court of Appeals, but there can be no assurance our appeal will be successful. If Teva’s commercial efforts are successful, they may materially harm our results of operations and financial condition, even if our appeal is successful and Teva is required to withdraw its product and pay us damages. We have made available our own generic version of Korlym.
We also have litigation settlements with Sun and Hikma that allow them to begin selling mifepristone, with customary restrictions, provided the FDA has approved their products and Teva’s generic product remains commercially available. The
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availability of generic versions of Korlym from Sun or Hikma could materially harm our results of operations and financial condition, even if our on-going appeal against Teva is successful and Teva, Sun and Hikma were required to withdraw their products and pay us damages. Please see “Part II, Item 1, Legal Proceedings” for additional details.
The availability of generic Korlym could cause our revenue to decline and materially harm our results of operations and financial position, by reducing the number of tablets we sell or lowering their price. It may also cause our revenue to be materially less than the public guidance we have provided, which would likely cause the price of our common stock to decline.
Legal action to enforce or defend intellectual property rights is complex, costly and involves significant commitments of management time. Other companies may seek FDA approval to market generic versions of Korlym, in which case we will vigorously protect our intellectual property. However, there can be no assurance our efforts will be successful.
Public perception of mifepristone or legislation limiting or barring its use for termination of early pregnancy may limit our ability to sell our medications.
The active ingredient in Korlym, mifepristone, is approved by the FDA in another drug for the termination of early pregnancy. In 2022, the United States Supreme Court published its decision in the case of Dobbs v. Jackson Women’s Health Organization (“Dobbs”), which overturned Roe v. Wade, the 1973 Supreme Court decision that had established a woman’s right to terminate her pregnancy, subject to certain limitations. Dobbs has stimulated many states to enact laws restricting the legality of abortion and mifepristone, including during early pregnancy and under specific conditions of use. More laws banning or heavily restricting termination of pregnancy may be adopted and existing laws may be made more restrictive. On June 13, 2024, in a highly publicized case, the Supreme Court ruled against plaintiffs seeking to restrict access to mifepristone for terminating pregnancy, holding that they lacked standing (i.e., the right to sue), thus preserving current access to mifepristone. Because the Supreme Court’s decision was made solely on procedural grounds, the ruling does not necessarily foreclose other challenges to the continued availability of mifepristone. The timing and outcome of any subsequent cases, as well as additional legislative changes are uncertain. In addition, heightened public awareness of mifepristone as an abortifacient may draw the attention of hostile state government officials or political activists to Korlym – as could additional public debate concerning current or proposed restrictions on the distribution of mifepristone. This may be the case even though (i) Korlym is not approved for the termination of pregnancy, (ii) we do not promote it for that use and (iii) we have taken measures to minimize the chance that it will accidentally be prescribed to a pregnant woman.
New laws, government regulations, or changes to existing laws and regulations could make it difficult or impossible for us to obtain acceptable prices or adequate insurance coverage and reimbursement for Korlym, which would adversely affect our results of operations and financial position.
The commercial success of Korlym depends on the availability of acceptable pricing and adequate insurance coverage and reimbursement. Government payers, including Medicare, Medicaid and the Veterans Administration, as well as private insurers and health maintenance organizations, are increasingly attempting to contain healthcare costs by limiting reimbursement for medicines. In many foreign markets, drug prices and the profitability of prescription medications are subject to government control. In the United States, we expect that there will continue to be federal and state proposals for similar controls. Also, the trends toward managed health care in the United States and recent laws and legislation intended to increase the public visibility of drug prices and reduce the cost of government and private insurance programs could significantly influence the purchase of health care services and products and may result in lower prices for Korlym. If government or private payers cease to provide adequate and timely coverage, pricing and reimbursement for Korlym, physicians may not prescribe the medication and patients may not purchase it, even if it is prescribed, or the price we receive may be reduced, which would reduce our revenue.
In the United States, there have been and continue to be legislative initiatives to contain healthcare costs. The IRA significantly changed the way Medicare pays for prescription drugs. The IRA requires the Secretary of the U.S. Department of Health and Human Services (“HHS”) to negotiate Medicare prices for selected drugs and biologicals, including both physician-administered products covered under Medicare’s Part B benefit and self-administered drugs such as Korlym that are covered under the Part D benefit. Each year, the Secretary will select for price negotiation a specified number of negotiation-eligible drugs with the highest total Part B or D expenditures over the preceding 12-month period. To be eligible for price negotiation a drug must have been on the market for at least seven years without generic competition. Orphan drugs indicated for only one rare disease or condition and drugs with less than $200 million in annual Medicare expenditures are exempt from the negotiation program. For the first two years of the program, 2026 and 2027, only Part D drugs are eligible. The Secretary will publish the negotiated price, known as the “Maximum Fair Price” (“MFP”), for each of the selected products. Manufacturers of selected drugs would be required to offer the drug for Medicare recipients at the MFP. Manufacturers who fail to negotiate with the Secretary or offer their drug to Medicare recipients at the MFP can face significant civil money penalties or excise tax
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liability on sales of that drug. If Korlym or any drug we commercialize becomes eligible for Medicare negotiation, the revenue we generate from sales of that drug may be significantly reduced.
The IRA also establishes an inflation rebate program that requires manufacturers to pay rebates to the Medicare program if any of the medications they provide Medicare recipients increase in price faster than the rate of inflation. The Part D inflation rebate provision went into effect on October 1, 2022. Although manufacturers are generally familiar with inflation rebates under the Medicaid program, where they have existed for decades, the IRA represents the first time that inflation rebates have been extended to the Medicare program. The inflation rebate provision applies to any medication sold to Medicare recipients, whether or not that medication is subject to Medicare price negotiation.
Beginning in 2025, the IRA will also shift a significant portion of the Medicare beneficiary costs from the government and beneficiaries to manufacturers. We anticipate that this provision will significantly limit the revenue we receive and may materially reduce our revenue and profits.
We make grants to independent charitable foundations that help financially needy patients with their premium, co-pay, and co-insurance obligations with respect to their Cushing’s syndrome treatment, whether that treatment includes Korlym or not. There has been enhanced scrutiny of company-sponsored patient assistance programs, including insurance premium and co-pay assistance programs and donations to third-party charities that provide such assistance. As a result of this scrutiny, these assistance programs and charities may decide to reduce or eliminate entirely the assistance they provide to patients, which could result in fewer patients receiving the financial support they need to cover the cost of their Cushing’s syndrome care, including the cost of medication, which may include Korlym.
We expect governmental oversight and scrutiny of pharmaceutical companies to increase and that there will be additional attempts to change the healthcare system in ways that could harm our ability to sell Korlym and any other drugs we commercialize profitably, including new policies intended to curb healthcare costs, such as federal and state controls on reimbursement for drugs (including under Medicare and commercial health plans), new or increased requirements to pay prescription drug rebates and penalties to government health care programs and policies that require drug companies to disclose and justify the prices they charge.
Other companies offer different medications to treat patients with Cushing’s syndrome. The availability of competing treatments could limit our revenue from Korlym.
Since 2012, a medication owned by the Italian pharmaceutical company Recordati-S.p.A., the somatostatin analogue Signifor® (pasireotide) Injection, has been marketed in both the United States and the EU for adult patients with Cushing’s disease (a subset of Cushing’s syndrome). On March 6, 2020, the FDA granted Recordati approval to market another cortisol synthesis inhibitor, Isturisa® (osilodrostat) tablets, to treat patients with Cushing’s disease. Osilodrostat is approved in the EU for the treatment of patients with Cushing’s syndrome.
On December 30, 2021, Xeris received FDA approval to market the cortisol synthesis inhibitor Recorlev® (levoketoconazole) to treat patients with Cushing’s syndrome in the United States. Levoketoconazole is an enantiomer of the generic anti-fungal medication, ketoconazole, that is prescribed off-label to treat patients with Cushing’s syndrome.
Osilodrostat and levoketoconazole have been designated orphan drugs in both the EU and the United States.
Physician preference for any of these medications, or for the off-label use of generic medications such as ketoconazole, to treat patients with Cushing’s syndrome could reduce our revenue materially and harm our results of operations, which would cause our stock price to decline.
We depend on vendors to manufacture Korlym’s active ingredient, form it into tablets, package it and dispense it to patients. We also depend on vendors to manufacture the active pharmaceutical ingredient (“API”) and capsules or tablets for our product candidates. If our suppliers become unable or unwilling to perform these functions and we cannot transfer these activities to other vendors in a timely manner, our business will be harmed.
In the event any of our vendors fails to perform its contractual obligations to us or is materially impaired in its performance, we may experience disruptions and delays in our ability to deliver Korlym to patients or investigational drugs to patients in our clinical trials, which would adversely affect our business, results of operations and financial position.
Our single specialty pharmacy, Optime, dispenses Korlym and performs related pharmacy and patient support services, including the collection of payments from insurers representing more than 99 percent of our revenue. If Optime does not adhere to its agreements with payers or does not continue to meet regulatory requirements concerning pharmacy operations, it may not be able to collect on our behalf some or all of the payments due to us. In addition, if Optime becomes unable or unwilling to perform its obligations under our agreement, we may not be able to dispense Korlym in a timely manner to some or all of our
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patients. Effective April 1, 2024, we extended our agreement with Optime through March 31, 2027, with automatic renewal for successive three-year terms. The agreement is subject to customary termination provisions, including the right of Optime to terminate in the event of a material breach by us that we do not cure in a reasonable period of time after receiving written notice. In addition, we may terminate the agreement for convenience.
The facilities used by our vendors to manufacture and package the API and drug product for Korlym and our product candidates and distribute them to hospitals, clinics and patients, must be approved by government regulators in the United States, Europe, and elsewhere. We do not control the activities of these vendors, including whether they maintain adequate quality control and hire qualified personnel. We are dependent on them for compliance with the regulatory requirements known as current good manufacturing practices (“cGMPs”), which are subject to change at the regulators’ discretion. If our vendors cannot manufacture material that conforms to our specifications and the strict requirements of the FDA or others, they will not be able to maintain regulatory authorizations for their facilities and we could be prohibited from using the API or drug product they have provided. If the FDA, European Medicines Agency (“EMA”), the Medicines and Healthcare products Regulatory Agency (“MHRA”) or other regulatory authorities withdraw regulatory authorizations of these facilities, we may need to find alternative vendors or facilities, which would be time-consuming, complex and expensive and could significantly hamper our ability to develop, obtain regulatory approval for and market our products. Sanctions could be imposed on us, including fines, injunctions, civil penalties, refusal of regulators to approve our product candidates, delays, suspensions or withdrawals of approvals, seizures or recalls of products, operating restrictions and criminal prosecutions, any of which could harm our business. In addition, our reputation as a reliable sponsor of clinical studies would be harmed, which would make it more difficult for us to develop our drug candidates.
Natural disasters, such as earthquakes, fires, extreme weather events or widespread outbreaks of a deadly disease such as COVID-19, could disrupt our commercial and clinical activities or damage or destroy clinical trial sites, our office spaces, the residences of our employees or the facilities or residences of our vendors, contractors or consultants, which could significantly harm our operations.
A resurgence of COVID-19 or the widespread occurrence of another deadly illness could adversely affect our business, operations and financial results. The COVID-19 pandemic made it difficult to grow our commercial business and slowed the pace of some of our clinical trials.
We are also vulnerable to natural disasters, including earthquakes, fires, hurricanes, floods, blizzards and the extended periods of extreme heat, cold and precipitation made more frequent and severe by global warming. For example, our headquarters are in the San Francisco Bay Area, which experiences earthquakes, wildfires and flooding. Our specialty pharmacy, tablet manufacturers and warehouses are in areas subject to hurricanes and tornadoes. All our activities, as well as the activities of our vendors, consultants, clinical investigators, patients, physicians and regulators, are subject to the risks posed by global warming.
The loss of life, property damage and disruptions to electrical power distribution, communications, travel and shipping caused by natural disasters could make it difficult or impossible to conduct our commercial activities or complete our drug discovery activities or clinical trials. Patients may be unwilling or unable to travel to clinical trial sites, for example, or clinical materials or data may be lost.
Our insurance, if available at all, would likely be insufficient to cover losses resulting from disasters or other business interruptions.
If we are unable to maintain regulatory approval of Korlym or if we fail to comply with other requirements, we will be unable to generate revenue and may be subject to penalties.
We are subject to oversight by the FDA and other regulatory authorities in the United States and elsewhere with respect to our research, testing, manufacturing, labeling, distribution, adverse event reporting, storage, advertising, promotion, recordkeeping and sales and marketing activities. These requirements include submissions of safety information, annual updates on manufacturing activities and continued compliance with FDA regulations, including cGMPs, good laboratory practices and good clinical practices (“GCPs”), all of which are subject to change without notice and at the regulators’ sole discretion. Foreign regulatory authorities have comparable requirements and enforcement mechanisms, which are also subject to change. The FDA and other regulators enforce these regulations through inspections of us and the laboratories, manufacturers and clinical sites we use. Discovery of previously unknown problems with a product or product candidate, such as adverse events of unanticipated severity or frequency or deficiencies in manufacturing processes or management, as well as failure to comply with current or future FDA or other U.S. or foreign regulatory requirements, may subject us to substantial civil and criminal penalties, injunctions, holds on clinical trials, product seizure, refusal to permit the import or export of products, restrictions on product marketing, withdrawal of the product from the market, product recalls, total or partial suspension of production, refusal
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to approve pending new drug applications (“NDAs”) or supplemental NDAs, and suspension or revocation of product approvals.
We may be subject to civil or criminal penalties if our marketing of Korlym violates FDA regulations or health care fraud and abuse laws.
We are subject to FDA regulations governing the promotion and sale of medications. Although physicians are permitted to prescribe drugs for any indication they choose, manufacturers may only promote products for their FDA-approved use. All other uses are referred to as “off-label,” manufacturers are prohibited from engaging in any “off-label” promotion. In the United States, we market Korlym to treat hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing’s syndrome who have type 2 diabetes mellitus or glucose intolerance and for whom surgery has failed or is not an option. Among other activities, we provide promotional materials and training programs to physicians covering the use of Korlym for this indication. The FDA may change its policies or enact new regulations at any time that may restrict our ability to promote our products, which could adversely impact our business.
If the FDA were to determine that we engaged in off-label promotion, the FDA could require us to change our practices and subject us to regulatory enforcement actions, including issuance of a public “warning letter,” untitled letter, injunction, seizure, civil fine or criminal penalties. Other federal or state enforcement authorities might act if they believe that the alleged improper promotion led to the submission and payment of claims for an unapproved use, which could result in significant fines or penalties under other statutory authorities, such as laws prohibiting false claims for reimbursement. Even if it is determined that we are not in violation of these laws, we may receive negative publicity, incur significant expenses and be forced to devote management time to defending our position.
In addition to laws prohibiting off-label promotion, we are also subject to federal and state healthcare fraud and abuse laws and regulations designed to prevent fraud, kickbacks, self-dealing and other abusive practices. The United States healthcare laws and regulations that may affect our ability to operate include, but are not limited to:
the federal Anti-Kickback Statute, which prohibits, among other things, knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual for, or the purchase, order or recommendation of, any good or service for which payment may be made under federal health care programs such as Medicare and Medicaid. And, although we structure our applicable business arrangements in accordance with the safe harbors, it is difficult to determine exactly how the law will be applied in specific circumstances. Accordingly, it is possible that certain practices of ours may be challenged under the federal Anti-Kickback Statute. From a liability perspective, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation;
federal false claims laws, including, without limitation, the False Claims Act, which prohibit any person from knowingly presenting, or causing to be presented, a false claim for payment to the federal government, or knowingly making, or causing to be made, a false statement to get a false claim paid. The federal False Claims Act is unique in that it allows private individuals (whistleblowers) to bring actions on behalf of the federal government via qui tam actions. Importantly, under the False Claims Act the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act;
the federal Civil Monetary Penalties law, which prohibits, among other things, offering or transferring remuneration to a federal healthcare beneficiary that a person knows or should know is likely to influence the beneficiary’s decision to order or receive items or services reimbursable by the government from a particular provider or supplier;
HIPAA, which created federal criminal laws that prohibit executing a scheme to defraud any health care benefit program or making false statements relating to health care matters; similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation;
federal “sunshine” laws, including the federal Physician Payment Sunshine Act (or sometimes referred to as the Open PaymentsTM Program), that require transparency regarding financial arrangements with health care providers, such as the reporting and disclosure requirements imposed by the Patient Protection and Affordable Care Act (“ACA”) on drug manufacturers regarding any “transfer of value” made or distributed to physicians, certain non-physician practitioners, teaching hospitals, and ownership or investment interests held by physicians and their immediate family members;
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federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers;
state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payer, including commercial insurers; state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers; and
state laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures and pricing information.
The risk of being found in violation of these laws and regulations is increased by the fact that many of them have not been definitively interpreted by regulatory authorities or the courts and their provisions are open to a variety of interpretations. Because of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available under them, it is possible that some of our business activities, including our relationships with physicians and other healthcare providers (some of whom recommend, purchase and/or prescribe our products) and the manner in which we promote our products, could be subject to challenge and scrutiny. We are also exposed to the risk that our employees, independent contractors, principal investigators, consultants, vendors, distributors and contract research organizations (“CROs”) may engage in fraudulent or other illegal activity. Although we have policies and procedures prohibiting such activity, it is not always possible to identify and deter misconduct and the precautions we take may not be effective in controlling unknown risks or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to comply with applicable laws and regulations.
In November 2021, we received a records subpoena from the United States Attorney’s Office for the District of New Jersey (the “NJ USAO”) seeking information relating to the sale and promotion of Korlym, our relationships with and payments to health care professionals who can prescribe or recommend Korlym and prior authorizations and reimbursement for Korlym. The NJ USAO has informed us that it is investigating whether any criminal or civil violations by us occurred in connection with the matters referenced in the subpoena. It has also informed us that it does not currently consider us a defendant but rather an entity whose conduct is within the scope of the government’s investigation. We are cooperating with the investigation. Please see “Part II, Item 1, Legal Proceedings” for additional details.
If we are found in violation of any of the laws described above or any other government regulations, we may be subject to civil and criminal penalties, damages, fines, exclusion from governmental health care programs, a corporate integrity agreement or other agreement to resolve allegations of non-compliance, individual imprisonment, and the curtailment or restructuring of our operations, any of which could adversely affect our financial results and ability to operate.
Risks Related to our Research and Development Activities
Vendors perform many of the activities necessary to carry out our clinical trials, including drug product distribution, trial management and oversight and data collection and analysis. Failure of these vendors to perform their duties or meet expected timelines may prevent or delay approval of our product candidates.
Third-party clinical investigators and clinical sites enroll patients and CROs manage many of our trials and perform data collection and analysis. Although we control only certain aspects of these third parties’ activities, we are responsible for ensuring that every study adheres to its protocol and meets regulatory and scientific standards. If any of our vendors does not perform its duties or meet expected deadlines or fails to adhere to applicable GCPs, or if the quality or accuracy of the data it produces is compromised, affected clinical trials may be extended, delayed or terminated and we may be unable to obtain approval for our product candidates. Outside parties may have staffing difficulties, may undergo changes in priorities or may become financially distressed, adversely affecting their willingness or ability to conduct our clinical trials. Problems with the timeliness or quality of the work of a CRO may lead us to seek to terminate the relationship and use an alternative service provider. However, making this change may be costly and may delay our trials, and it may be challenging to find a replacement organization that can conduct our trials in an acceptable manner and at an acceptable cost. Failure of our manufacturing vendors to perform their duties or comply with cGMPs may require us to recall drug product or repeat clinical trials, which would delay regulatory approval. If our agreements with any of these vendors terminate, we may not be able to enter into alternative arrangements in a timely manner or on reasonable terms.
Our efforts to discover, develop and secure regulatory approval for our product candidates may not succeed. Clinical drug development is lengthy, expensive and often unsuccessful. Results of early studies and trials are often not predictive of later trial results. Failure can occur at any time. Even if we deem that our product candidates clinical trial
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results demonstrate safety and efficacy, regulatory authorities may not agree. Failure to obtain or maintain regulatory approvals for our product candidates would prevent us from commercializing them.
Clinical development is costly, time-consuming and unpredictable. Positive data from clinical trials are susceptible to varying interpretations, which could delay, limit or prevent regulatory approval. The results from early clinical trials are often not predictive of results in later clinical trials. Product candidates may fail to show the desired safety and efficacy traits despite having produced positive results in preclinical studies and initial clinical trials. Many companies have suffered significant setbacks in late-stage clinical trials due to lack of efficacy or unanticipated or unexpectedly severe adverse events.
Our current clinical trials may prove inadequate to support marketing approvals. Even trials that generate positive results may have to be confirmed in much larger, more expensive and lengthier trials before we could seek regulatory approval.
Clinical trials may take longer to complete, cost more than expected and fail for many reasons, including:
failure to show efficacy or acceptable safety;
slow patient enrollment or delayed activation of clinical trial sites;
delays obtaining regulatory permission to start a trial, changes to the size or design of a trial or changes in regulatory requirements for a trial already underway;
inability to secure acceptable terms with vendors and an appropriate number of clinical trial sites;
delays or inability to obtain institutional review board (“IRB”) approval at prospective trial sites;
failure of patients or investigators to comply with the clinical trial protocol;
unforeseen safety issues; and
negative findings of inspections of clinical sites or manufacturing operations by us, the FDA or other authorities.
A trial may also be suspended or terminated by us, the trial’s data safety monitoring board, the IRBs governing the sites where the trial is being conducted or the FDA for many reasons, including failure to comply with regulatory requirements or clinical protocols, negative findings in an inspection of our clinical trial operations or trial sites by the FDA or other authorities, unforeseen safety issues, failure to demonstrate a benefit or changes in government regulations.
At any time prior to the regulatory approval of a product candidate, we may decide, or the FDA or other regulatory authorities may require us, to conduct more pre-clinical or clinical studies, provide additional analysis of existing data or change the size or design of a trial already underway. Such additional or changed requirements, which regulators may impose in their sole discretion, may delay or prevent the completion of development, submission of an NDA or the completion of regulatory review, which would increase our costs and adversely impact future revenue. Even if we conduct the clinical trials and supportive studies that we consider appropriate and the results are positive, we may not receive regulatory approval. Following regulatory approval, there is no assurance of commercial success.
We may be unable to obtain or maintain regulatory approvals for our product or product candidates, which would prevent us from commercializing our product candidates.
We cannot sell a product without the approval of the FDA or comparable foreign regulatory authority. Obtaining such approval is difficult, uncertain, lengthy and expensive. Failure can occur at any stage. In order to receive FDA approval for a new drug, we must demonstrate to the FDA’s satisfaction that the new drug is safe and effective for its intended use and that our manufacturing processes comply with cGMPs. Our inability or the inability of our vendors to comply with applicable FDA and other regulatory requirements can result in delays in or denials of new product approvals, warning letters, untitled letters, fines, consent decrees restricting or suspending manufacturing operations, injunctions, civil penalties, recall or seizure of products, total or partial suspension of product sales and criminal prosecution. We may seek to commercialize our products in international markets, which would require us to receive a marketing authorization and, in many cases, pricing approval, from the appropriate regulatory authorities. Approval procedures vary between countries and can require additional pre-clinical or clinical studies. Obtaining approval may take longer than it does in the United States. Although approval by the FDA does not ensure approval by regulatory authorities in other countries, and approval by one foreign regulatory authority does not ensure approval by others, failure or delay in obtaining regulatory approval in one country may have a negative effect on the regulatory process in others. Any of these or other regulatory actions could materially harm our business and financial condition.
If we receive regulatory approval for a product candidate, we will be subject to ongoing requirements and oversight by the FDA and other regulatory authorities, such as continued safety and other reporting requirements and possibly post-approval
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marketing restrictions and additional costly clinical trials. If we are not able to maintain regulatory compliance, we may be required to stop development of a product candidate or to stop selling a product that has already been approved. We may also be subject to product recalls or seizures. Future governmental action or changes in regulatory authority policy or personnel may also result in delays or rejection of pending or anticipated product approvals.
Our products and product candidates may cause undesirable side effects that halt their clinical development, prevent their regulatory approval, limit their commercial potential or cause us significant liability.
Patients in clinical trials report changes in their health, including new illnesses, injuries and discomforts, to their study doctor. Often, it is not possible to determine whether or not these conditions were caused by the drug candidate being studied or something else. As we test our product candidates in larger, longer and more extensive clinical trials, or as use of them becomes more widespread if we receive regulatory approval, patients may report serious adverse events that did not occur or went undetected in previous trials. Many times, serious side effects are only detected in large-scale, Phase 3 clinical trials or following commercial approval.
Adverse events reported in clinical trials can slow or stop patient recruitment, prevent enrolled patients from completing a trial and could give rise to liability claims. Regulatory authorities could respond to reported adverse events by interrupting or halting our clinical trials or limiting the scope of, delaying or denying marketing approval. If we elect, or are required by authorities, to delay, suspend or terminate a clinical trial or commercialization efforts, the commercial prospects of the affected product candidates or products may be harmed and our ability to generate product revenues from them may be delayed or eliminated.
If one of our product candidates receives marketing approval, and we or others later identify undesirable side effects or adverse events, potentially significant negative consequences could result, including but not limited to:
regulatory authorities may suspend, limit or withdraw approvals of such product;
regulatory authorities may require additional warnings on the label, including “boxed” warnings, or issue safety alerts and other safety information about the product;
we may be required to change the way the product is administered or conduct additional studies or clinical trials;
we may be required to create a Risk Evaluation and Mitigation Strategy, which could include a medication guide outlining the risks of such side effects for distribution to patients, a communication plan for healthcare providers and/or other elements to assure safe use;
the product may become less competitive;
we may be subject to fines, injunctions or the imposition of criminal penalties; and
we could be sued and held liable for harm caused to patients.
Any of these events could seriously harm our business.
Risks Related to our Capital Needs and Financial Results
We may need additional capital to fund our operations or for strategic reasons. Such capital may not be available on acceptable terms or at all.
We are dependent on revenue from the sale of Korlym and our cash reserves to fund our commercial operations and development programs. If Korlym revenue declines significantly, we may need to curtail our operations or raise funds to support our plans. We may also choose to raise funds for strategic reasons. We cannot be certain funding will be available on acceptable terms or at all. Equity financing would cause dilution, debt financing may involve restrictive covenants. Neither type of financing may be available to us on attractive terms or at all. If we obtain funds through collaborations with other companies, we may have to relinquish rights to one or more of our product candidates. If our revenue declines and our cash reserves are depleted, and if adequate funds are not available from other sources, we may have to delay, reduce the scope of, or eliminate one or more of our development programs.
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Risks Relating to our Intellectual Property
To succeed, we must secure, maintain and effectively assert adequate patent protection for the composition and methods of use of our proprietary, selective cortisol modulators and for the use of Korlym to treat Cushing’s syndrome.
Patents are uncertain, involve complex legal and factual questions and are frequently the subject of litigation. The patents issued or licensed to us may be challenged at any time. Competitors may take actions we believe infringe our intellectual property, causing us to take legal action to defend our rights. Intellectual property litigation is lengthy, expensive and requires significant management attention. Outcomes are uncertain. If we do not protect our intellectual property, competitors may erode our competitive advantage. Please see “Part II, Item 1, Legal Proceedings” for additional information.
Our patent applications may not result in issued patents and patents issued to us may be challenged, invalidated, held unenforceable or circumvented. Our patents may not prevent third parties from producing competing products. The foreign countries where we may someday operate may not protect our intellectual property to the extent the laws of the United States do. If we fail to obtain adequate patent protection in other countries, others may produce products in those countries based on our technology.
Risks Related to our Stock
The price of our common stock fluctuates widely and is likely to continue to do so. Opportunities for investors to sell shares may be limited.
We cannot assure investors that a liquid trading market for our common stock will exist at any particular time. As a result, holders of our common stock may not be able to sell shares quickly or at the current market price. During the 52-week period ended October 23, 2024, our average daily trading volume was 1,105,185 shares and the intra-day sales prices per share of our common stock on The Nasdaq Stock Market ranged from $20.84 to $50.07. As of October 23, 2024, our officers, directors and principal stockholders beneficially owned 21 percent of our common stock.
Our stock price can experience extreme price and volume fluctuations that are unrelated or disproportionate to our operating performance or prospects. Securities class action lawsuits are often instituted against companies following periods of stock market volatility. Such litigation is costly and diverts management’s attention from productive efforts.
Factors that may cause the price of our common stock to fluctuate rapidly and widely include:
actual or anticipated variations in our operating results or changes to any public guidance we have provided;
actual or anticipated timing and results of our clinical trials;
actual or anticipated regulatory approvals of our product candidates;
disputes or other developments relating to our intellectual property, including developments in generic-related litigation;
changes in laws or regulations applicable to the pricing, availability of insurance reimbursement, or approved uses of Korlym, our product candidates or our competitors’ products;
short-selling of our common stock, the publication of negative opinions about our business or other market manipulation activities that are intended to lower our stock price or increase its volatility;
sales of a substantial number of shares of our stock in the public market, leading to reductions in its price;
changes in estimates or recommendations by securities analysts or the failure of our performance to meet the published expectations of those analysts or public guidance we have provided;
purchases of our common stock pursuant to our stock repurchase program (the “Stock Repurchase Program”) or changes to that program;
general market and economic conditions;
changes in the expected or actual timing of our competitors’ development programs and the approval of competing products;
purchases or sales of our common stock by our officers, directors or stockholders;
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technological innovations by us, our collaborators or our competitors;
conditions in the pharmaceutical industry, including the market valuations of companies similar to ours;
additions or departures of key personnel;
announcements by us or our competitors of significant acquisitions, strategic partnerships, joint ventures, collaborations or capital commitments; and
additional financing activities.
Our stock price may decline if our financial performance does not meet the guidance we have provided to the public, estimates published by research analysts or other investor expectations.
The guidance we provide as to our expected revenue is only an estimate of what we believe is realizable at the time we give such guidance. Our revenue depends on many factors, including, without limitation, the efficacy of our sales and marketing efforts, the price we receive from private and government payors, competition from alternate treatments for patients with Cushing’s syndrome, including from generic versions of Korlym and changes in government regulations. Our guidance estimate considers all of these factors, but they are difficult to predict. As a result, our revenue may vary materially from our guidance. Research analysts publish estimates of our future revenue and earnings based on their own analysis. The revenue guidance we provide may be one factor they consider when determining their estimates. If our revenue is materially less than the guidance we or the research analysts who cover our stock provide investors, our stock price may decline.
We have in the past and may in the future be subject to short selling strategies that may drive down the market price of our common stock and increase its volatility.
Short sellers have, and likely will continue to, attempt to drive down the price of our common stock. Short selling is the practice of selling stock the seller does not own with the intention of buying it back later at a lower price, thereby profiting from any decline in the price of the stock between the time it is sold and the time it is repurchased. To support their efforts, short sellers often publish, or arrange for others to publish, negative opinions regarding the relevant issuer and its business prospects. These publications are often made to appear as if they were objective journalism or unbiased “research reports” of the type distributed by credible Wall Street firms and independent research analysts. Short seller publications are not regulated by any governmental, self-regulatory organization or other authority in the United States and the opinions they express are often based on distortions, omissions or fabrications. Short attacks supported by such publications have, in the past, led to selling of our stock and at least temporary reductions in its price. Companies that are subject to unfavorable allegations, even if untrue, may have to expend a significant amount of resources to investigate such allegations and/or defend themselves, including shareholder suits against the company that may be prompted by such allegations. We have been, and may in the future be, the subject of shareholder suits prompted by allegations made by short sellers.
General Risk Factors
We need to increase the size of our organization and may experience difficulties in managing growth.
Our commercial and research and development efforts are constrained by our limited administrative, operational and management resources. To date, we have relied on a small management team. Growth will impose significant added responsibilities on members of management, including the need to recruit and retain additional employees. Our financial performance and ability to compete will depend on our ability to manage growth effectively. To that end, we must:
continue to add talented, experienced personnel to our endocrine, oncology and emerging markets businesses;
manage our clinical trials, research and manufacturing activities effectively;
hire more general management, clinical development, administrative and sales and marketing personnel; and
continue to develop our administrative systems and controls.
Failure to accomplish any of these tasks could harm our business.
If we lose key personnel or are unable to attract more skilled personnel, we may be unable to pursue our product development and commercialization goals.
Our ability to operate successfully and manage growth depends upon hiring and retaining skilled managerial, scientific, sales, marketing and financial personnel. The job market for qualified personnel is intensely competitive and turnover rates
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have reached record highs within our industry and the geographical areas from which we recruit. We depend on the principal members of our management and scientific staff. Any officer or employee may terminate his or her relationship with us at any time and work for a competitor. We do not have employment insurance covering any of our personnel. The loss of key individuals could delay our research, development and commercialization efforts.
We are subject to regulations and other legal obligations relating to drug development and commercialization, the conduct of business as an issuer of publicly traded securities and individual privacy and data protection. Compliance with these obligations is complex and costly. Failure to comply could materially harm our business.
New laws and regulations, as well as changes to existing laws and regulations, including statutes and regulations concerning taxes and the development, approval, marketing and pricing of medications, the provisions of the ACA requiring the reporting of aggregate spending related to health care professionals, the provisions of the Sarbanes-Oxley Act of 2002, the Dodd Frank Act of 2010 and rules adopted by the SEC and by The Nasdaq Stock Market have and will likely continue to increase our cost of doing business and divert management’s attention from revenue-generating activities.
We and our partners are subject to federal, state and foreign laws and regulations concerning data privacy and security, including HIPAA and the EU General Data Protection Regulation (“GDPR”). These and other regulatory frameworks are evolving rapidly as new rules are enacted and existing ones updated and made more stringent.
In the United States, numerous federal and state laws and regulations, including state data breach notification laws, state health information privacy, laws, and federal and state consumer protection laws and regulations (e.g., Section 5 of the Federal Trade Commission Act), that govern the collection, use, disclosure, and protection of health-related and other personal information could apply to our operations or the operations of our partners. In addition, we may obtain health information from third parties (including research institutions from which we obtain clinical trial data) that are subject to privacy and security requirements under HIPAA. Depending on the facts and circumstances, we could be subject to criminal penalties if we knowingly obtain, use, or disclose individually identifiable health information maintained by a HIPAA-covered entity in a manner that is not authorized or permitted by HIPAA.
Even when HIPAA does not apply, according to the Federal Trade Commission (the “FTC”), violating consumers’ privacy or failing to take appropriate steps to keep consumers’ personal information secure may constitute unfair acts or practices in or affecting commerce in violation of Section 5(a) of the Federal Trade Commission Act. The FTC expects a company’s data security measures to be reasonable and appropriate in light of the sensitivity and volume of consumer information it holds, the size and complexity of its business, and the cost of available tools to improve security and reduce vulnerabilities. Individually identifiable health information is considered sensitive data that merits stronger safeguards. In 2022, the FTC also began a rulemaking proceeding to develop additional data privacy rules and requirements, which may add additional complexity to compliance obligations going forward.
In addition, certain state laws govern the privacy and security of health information in certain circumstances, some of which are more stringent than HIPAA and many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts. Failure to comply with these laws, where applicable, can result in the imposition of significant civil and/or criminal penalties and private litigation. For example, the California Confidentiality of Medical Information Act imposes restrictive requirements regulating the use and disclosure of health information and other personally identifiable information. Further, the California Consumer Privacy Act, or the CCPA, which took effect on January 1, 2020, created individual privacy rights for California consumers and increased the privacy and security obligations of entities handling certain personal information. The CCPA provides for civil penalties for violations, as well as a private right of action for data breaches that is expected to increase data breach litigation. The CCPA may increase our compliance costs and potential liability. Further, the California Privacy Rights Act, or CPRA, revised and expanded the CCPA, adding additional data protection obligations on covered businesses, including additional consumer rights processes, limitations on data uses, new audit requirements for higher risk data, and opt outs for certain uses of sensitive data. It also created a new California data protection agency authorized to issue substantive regulations and could result in increased privacy and information security enforcement. The CPRA is in full effect as of January 1, 2023, and similar laws passed in Virginia, Colorado, Connecticut and Utah have taken effect and other states, including Texas, Florida, Oregon and Montana, have passed similar laws that will take effect in or after 2024. As a result, additional compliance investment and potential business process changes may be required. In the event that we are subject to or affected by HIPAA, the CCPA, the CPRA or other domestic privacy and data protection laws, any liability from failure to comply with the requirements of these laws could adversely affect our financial condition. Additional legislation proposed at the federal level and in other states, along with increased regulatory action, reflect a trend toward more stringent privacy legislation in the United States.
Outside the United States, many jurisdictions have or are in the process of enacting sweeping data privacy regulatory regimes. In Europe, the GDPR took effect in 2018, and is imposing stringent requirements for controllers and processors of
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personal data of individuals within the EEA, particularly with respect to clinical trials. The GDPR provides that EEA member states may make their own further laws and regulations limiting the processing of health data, which could limit our ability to use and share personal data or could cause our costs to increase and harm our business and financial condition. In addition, the GDPR increases the scrutiny that clinical trial sites located in the EEA should apply to transfers of personal data from such sites to countries that are considered to lack an adequate level of data protection, such as the United States. Recent legal developments have added complexity and compliance uncertainty regarding certain transfers of information from the EEA to the United States. Following EU court decisions, updated standard contractual clauses (“SCCs”) were adopted to account for these judicial decisions, imposing new requirements on data transfers. The revised SCCs must be used for relevant new data transfers from September 27, 2021, and existing SCC arrangements were required to be migrated by December 27, 2022. There is some uncertainty around whether the revised clauses can be used for all types of data transfers, particularly whether they can be relied on for data transfers to non-EEA entities subject to the GDPR. As supervisory authorities issue further guidance on personal data export mechanisms, including circumstances where the SCCs cannot be used, and/or start taking enforcement action, we could suffer additional costs, complaints and/or regulatory investigations or fines, and/or if we are otherwise unable to transfer personal data between and among countries and regions in which we operate, it could affect the manner in which we provide our services, the geographical location or segregation of our relevant systems and operations, and could adversely affect our financial results. The GDPR imposes substantial fines for breaches of data protection requirements, which can be up to four percent of global revenue for the preceding financial year or €20 million, whichever is greater, and it also confers a private right of action on data subjects for breaches of data protection requirements. Compliance with European data protection laws is a rigorous and time intensive process that may increase our cost of doing business, and despite those efforts, there is a risk that we may be subject to fines and penalties, litigation and reputational harm in connection with our European activities. From January 1, 2021, we have had to comply with the GDPR and separately the United Kingdom GDPR, which, together with the amended United Kingdom Data Protection Act 2018, retains the GDPR in United Kingdom national law, each regime having the ability to fine up to the greater of €20 million/ £17.5 million or 4 percent of global turnover. It is unclear how United Kingdom data protection laws and regulations will develop in the medium to longer term and these changes may lead to additional costs and increase our overall risk exposure. On June 28, 2021, the EC adopted an adequacy decision in favor of the United Kingdom, enabling data transfers from EU member states to the United Kingdom without additional safeguards. However, the United Kingdom adequacy decision will automatically expire in June 2025 unless the EC renews or extends that decision and remains under review by the Commission during this period.
Complying with U.S. and foreign privacy and security laws and regulations is complex and costly. Failure to comply by us or our vendors could subject us to litigation, government enforcement actions and substantial penalties and fines, which could harm our business.
We rely on information technology to conduct our business. A breakdown or breach of our information technology systems or our failure to protect confidential information concerning our business, patients or employees could interrupt the operation of our business and subject us to liability.
We store valuable confidential information relating to our business, patients and employees on our computer networks and on the networks of our vendors. In addition, we rely heavily on internet technology, including video conference, teleconference and file-sharing services, to conduct business. Despite our security measures, our networks and the networks of our vendors are at risk of break-ins, installation of malware or ransomware, denial-of-service attacks, data theft and other forms of malfeasance by persons seeking to commit fraud or theft, which could result in unauthorized access to, and/or misuse of, our clinical data or other confidential information, including confidential information relating to our patients or employees. We may continue to increase our cybersecurity risks, due to our reliance on internet technology and the number of our employees that are working remotely, which may create additional opportunities for cybercriminals to exploit vulnerabilities.
We and our vendors have experienced data breaches, theft, “phishing” attacks and other unauthorized access to confidential data and information. There can be no assurance that our cybersecurity systems and processes will prevent unauthorized access in the future that causes serious harm to us, our patients or employees. We may also experience security breaches that remain undetected for an extended period.
Disruptions or security breaches that result in the disclosure of confidential or proprietary information could cause us to incur liability and delay or otherwise harm our research, development and commercialization efforts. We may be liable for losses suffered by patients or employees or other individuals whose confidential information is stolen as a result of a breach of the security of the systems that we or third parties and our vendors store this information on, and any such liability could be material. Even if we are not liable for such losses, any breach of these systems could expose us to material costs in notifying affected individuals, as well as regulatory fines or penalties. In addition, any breach of these systems could disrupt our normal business operations and expose us to reputational damage and harm our business, operating results and financial condition. Any insurance we maintain against the risk of this type of loss may not be sufficient to cover actual losses or may not apply to the circumstances relating to any particular loss.
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Changes in federal, state and local tax laws may reduce our net earnings.
Our earnings are subject to federal, state and local taxes. We offset a portion of our earnings using net operating losses and our taxes using research and development tax credits, which reduces the amount of tax we pay. Some jurisdictions require that we pay taxes or fees calculated as a percentage of sales, payroll expense, or other indicia of our activities. Please see “Part I, Item 1, Notes to Unaudited Condensed Consolidated Financial Statements – Income Taxes.” Changes to existing tax laws could materially increase the amounts we pay, which would reduce our after tax net income.
Research analysts may not continue to provide or initiate coverage of our common stock or may issue negative reports.
The market for our common stock may be affected by the reports financial analysts publish about us. If any of the analysts covering us downgrades or discontinues coverage of our stock, the price of our common stock could decline rapidly and significantly. Paucity of research coverage may also adversely affect our stock price.
Any acquisition of Corcept shares through our stock repurchase program or, in certain cases, pursuant to the exercise of stock options, will reduce our cash reserves.
In January 2024, our Board of Directors authorized the repurchase of up to $200 million of our common stock pursuant to the Stock Repurchase Program. In addition, we sometimes accept, in our sole discretion, shares equal in value to any tax and exercise price liability due from option holders at the time of exercise and remit the applicable tax amounts to the tax authorities. Neither our Stock Repurchase Program nor the acceptance of shares at the time of options exercise require us to acquire shares. Furthermore, the Stock Repurchase Program may be modified, suspended or discontinued at any time without notice. It is possible that other uses of our capital would have been more advantageous or that our future capital requirements increase unexpectedly. By reducing our cash balance, our repurchases of common stock could hamper our ability to execute our plans, meet financial obligations or access financing.
Anti-takeover provisions in our charter and bylaws and under Delaware law may make an acquisition of us or a change in our management more expensive or difficult, even if an acquisition or a management change would be beneficial to our stockholders.
Provisions in our charter and bylaws may delay or prevent an acquisition of us or a change in our management. Some of these provisions allow us to issue preferred stock without any vote or further action by the stockholders, require advance notification of stockholder proposals and nominations of candidates for election as directors and prohibit stockholders from acting by written consent. In addition, a supermajority vote of stockholders is required to amend our bylaws. Our bylaws provide that special meetings of the stockholders may be called only by our Chairman, President or the Board of Directors and that the authorized number of directors may be changed only by resolution of the Board of Directors. These provisions may prevent or delay a change in our Board of Directors or our management, which our Board of Directors appoints. In addition, because we are incorporated in Delaware, we are governed by the provisions of Section 203 of the Delaware General Corporation Law. Section 203 may prohibit large stockholders, in particular those owning 15 percent or more of our outstanding voting stock, from merging or combining with us. These provisions in our charter and bylaws and under Delaware law could reduce the price that investors would be willing to pay for shares of our common stock.
Our officers, directors and principal stockholders, acting as a group, could significantly influence corporate actions.
As of October 23, 2024, our officers and directors beneficially owned 21 percent of our common stock. Acting together, these stockholders could significantly influence any matter requiring approval by our stockholders, including the election of directors and the approval of mergers or other business combinations. The interests of this group may not always coincide with our interests or the interests of other stockholders and may prevent or delay a change in control. This significant concentration of share ownership may adversely affect the trading price of our common stock because many investors perceive disadvantages to owning stock in companies with controlling stockholders.
ITEM 2.  UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
There were no unregistered sales of equity securities during the period covered by this report.
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Issuer Purchases of Equity Securities
The following table contains information relating to the repurchases of our common stock in the three months ended September 30, 2024 as part of our publicly announced stock repurchase program (in thousands, except average price per share):
Fiscal PeriodTotal Number of Shares RepurchasedAverage Price Paid Per Share
Dollar Amount of Shares That May Yet be Purchased Under the Program(1)
July 1, 2024 to July 31, 2024— $— $— 
August 1, 2024 to August 31, 2024270 34.03 186,842 
September 1, 2024 to September 30, 202474 33.97 184,329 
Total344 $34.02 $184,329 
(1) On January 8, 2024, our Board of Directors authorized the repurchase of up to $200 million of our common stock pursuant to our Stock Repurchase Program. The program may be modified, suspended or discontinued at any time without notice.
The following table contains information relating to the purchases of our common stock in the three months ended September 30, 2024 as part of the cashless net exercises of stock options (in thousands, except average price per share):

Fiscal Period
Total Number of Shares Purchased(1)
Average Price Per Share
Total Purchase Price of Shares(2)
July 1, 2024 to July 31, 2024322 $37.82 $12,175 
August 1, 2024 to August 31, 2024116 36.23 4,218 
September 1, 2024 to September 30, 202488 37.82 3,311 
Total526 $37.47 $19,704 
(1) In July 2024, we issued 518,670 shares of common stock as part of a net-share settlement of a cashless option exercise, of which 315,870 shares were surrendered to us in satisfaction of related exercise cost and tax obligations. In August 2024, we issued 217,081 shares of common stock as part of a net-share settlement of a cashless option exercise, of which 99,831 shares were surrendered to us. In September 2024, we issued 156,227 shares of common stock as part of a net-share settlement of a cashless option exercise, of which 78,239 shares were surrendered to us.
In July 2024, we issued 17,023 shares of common stock as part of restricted stock vesting, of which 6,070 shares were surrendered to us in satisfaction of related tax obligations. In August 2024, we issued 46,575 shares of common stock as part of restricted stock vesting, of which 16,601 shares were surrendered to us. In September 2024, we issued 26,924 shares of common stock as part of restricted stock vesting, of which 9,323 shares were surrendered to us.
(2) We paid $11.7 million to satisfy the tax withholding obligations associated with the net-share settlement of these cashless option exercises and vesting of restricted stock.
ITEM 3.  DEFAULTS UPON SENIOR SECURITIES
Not applicable.
ITEM 4.  MINE SAFETY DISCLOSURES
Not applicable.
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ITEM 5.  OTHER INFORMATION
Insider Trading Arrangements
During the quarter ended September 30, 2024, none of our directors and officers (as defined in Rule 16a-1(f) under the Exchange Act) adopted or terminated any contract, instruction or written plan for the purchase or sale of our securities that are intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) of the Securities Exchange Act of 1934, as amended, or any “non-Rule 10b5-1 trading arrangement,” as defined in Item 408(a) of Regulation S-K, other than as set forth in the table below.
NamePositionActionAdoption DateTotal Shares of Common Stock to be Sold
Expiration Date(1)
Daniel SwisherDirectorAdoption8/1/2024
Up to 26,400
10/13/2025
Joseph D. LyonChief Accounting and Technology OfficerAdoption8/30/2024
Up to 260,000
12/31/2025
Sean MaduckPresident, EndocrinologyAdoption9/5/2024
Up to 340,000
12/31/2025
(1) Each trading arrangement permits transactions through and including the earlier to occur of (a) the completion of all sales or (b) the date listed in the table.
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ITEM 6.  EXHIBITS
Exhibit
Number
 Description of Document
3.1 
3.2 
31.1 
31.2 
32.1 
32.2 
101 
The following materials from the registrant’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, formatted in Extensible Business Reporting Language (XBRL): (i) Unaudited Condensed Consolidated Balance Sheets at September 30, 2024 and December 31, 2023, (ii) Unaudited Condensed Consolidated Statements of Income for the three and nine month periods ended September 30, 2024 and 2023, (iii) Unaudited Condensed Consolidated Statements of Comprehensive Income for the three and nine month periods ended September 30, 2024 and 2023, (iv) Unaudited Condensed Consolidated Statements of Cash Flows for the nine month periods ended September 30, 2024 and 2023, (v) Unaudited Condensed Consolidated Statement of Stockholders’ Equity and (vi) Notes to Unaudited Condensed Consolidated Financial Statements.
104Cover Page Interactive Data File - the cover page XBRL tags are embedded within the Inline XBRL document.

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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
 CORCEPT THERAPEUTICS INCORPORATED
  
Date: October 30, 2024/s/ Joseph K. Belanoff
 Joseph K. Belanoff, M.D.
Chief Executive Officer
  
Date:
October 30, 2024/s/Atabak Mokari
 Atabak Mokari
 Chief Financial Officer
Date:October 30, 2024/s/Joseph D. Lyon
Joseph D. Lyon
Chief Accounting & Technology Officer

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