Analyst Sees Exelixis At Inflection Point Despite Mixed Trial Results
Analyst Sees Exelixis At Inflection Point Despite Mixed Trial Results
In its second-quarter earnings release, Exelixis, Inc. (NASDAQ:EXEL) announced that the final overall survival (OS) analysis for the phase 3 CONTACT-02 trial has been completed.
伊克力西斯公司（納斯達克股票代碼：EXEL）在其第二季度業績發佈中宣佈，第三期CONTACt-02試驗的最終總體生存（OS）分析已經完成。
This study evaluates cabozantinib in combination with atezolizumab compared with a second novel hormonal therapy (NHT) in patients with metastatic castration-resistant prostate cancer (mCRPC) and measurable soft-tissue disease who have progressed after treatment with one prior NHT.
該研究比較了卡博替尼聯合阿特伊珠單抗與第二個新的激素治療（NHT），用於轉移性去勢抵抗性前列腺癌（mCRPC）和可測量軟組織疾病的患者，這些患者在接受一種先前的NHT治療後已經進展。
Also Read: Bristol Myers, Exelixis Reveal 4-Year Follow-Up Results From Cancer Treatment Study.
同時閱讀：Bristol Myers和Exelixis公佈癌症治療研究的4年隨訪結果。
As previously reported, the CONTACT-02 study met one of its two primary endpoints, demonstrating a statistically significant benefit in progression-free survival (PFS) (hazard ratio: 0.65; p=0.0007) in the predefined PFS intent-to-treat population (i.e., the first 400 randomized patients).
正如之前報道的那樣，CONTACt-02研究實現了兩個主要終點的其中一個，在預定義的進展無病生存（PFS）意向治療總體人群（即，前400名隨機患者）中顯示出統計學有意義的益處（風險比：0.65；p = 0.0007）。
While the final OS continued to favor the combination of cabozantinib and atezolizumab, it did not achieve statistical significance.
雖然最終的OS仍然有利於卡博替尼聯合阿特伊珠單抗，但並沒有達到統計學意義。
The safety profile of the combination regimen was reflective of the known safety profiles for each single agent and was consistent with the known tolerability profile of approved immune checkpoint inhibitor-tyrosine kinase inhibitor combinations in advanced solid tumors.
該聯合方案的安全剖面反映了每個單一製劑的已知安全剖面，並且與晚期實體瘤批准的免疫檢查點抑制劑-酪氨酸激酶抑制劑聯合劑型的已知耐受性剖面一致。
Despite the trial update, the company intends to submit a supplemental marketing application to the FDA in 2024.
儘管有試驗更新，但該公司仍打算在2024年向美國FDA提交補充營銷申請。
Exelixis reported second-quarter adjusted EPS of $0.84, higher than $0.31 a year ago, beating the consensus of $0.30.
Exelixis報告的第二季度調整後每股收益爲0.84美元，高於去年同期的0.31美元，超過0.30美元的共識。
The sales increased to $637.2 million, beating the consensus of $465 million, up from $469.8 million a year ago, primarily due to increased sales volume and average net selling price.
銷售額增長至6,372百萬美元，高於去年同期的4,698百萬美元，主要是由於銷售量和平均淨售價的增加。
Guidance: Exelixis sees 2024 revenues of $1.975 billion—$2.075 billion versus a consensus of $1.88 billion and prior guidance of $1.825 billion—$1.925 billion.
指導：Exelixis預計2024年的營業收入爲19.75億美元至20.75億美元，而共識爲18.8億美元，先前的指導爲18.25億美元至19.25億美元。
William Blair writes that Exelixis has entered 2024 at an inflection point. The growth of its flagship Cabometyx franchise is stabilizing, while pipeline programs, especially zanzalintinib, are increasingly responsible for offsetting Cabometyx's market exclusivity expiry in 2031.
William Blair表示，Exelixis已經在2024年進入了一個拐點。旗艦Cabometyx系列藥物的增長正在穩定，而管線計劃（特別是zanzalintinib）越來越多地負責抵消Cabometyx在2031年市場獨佔的到期。
In the midterm, NETs and mCRPC could emerge as material growth opportunities for the franchise.
在中期內，NET和mCRPC可能成爲系列藥物的實質性增長機會。
"Ultimately, given the cash flow generation and EPS positivity, we believe Exelixis provides investors with a highly defensive investment profile," the analyst adds.
該分析師補充說：「最終，考慮到現金流的產生和EPS的積極性，我們認爲Exelixis爲投資者提供了高度防禦性的投資配置。」
The analyst reiterates the Outperform rating on Exelixis shares.
該分析師重申對Exelixis股票的表現評級。
Price Action: EXEL stock is up 13% at $26.49 at last check Wednesday.
價格走勢：EXEL股票上漲13％，最後報價26.49美元，星期三。
Photo via Shutterstock
圖片來自shutterstock。
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