Cabometyx
Search documents
EXEL Tops Q3 Earnings Estimates, Cabometyx Fuels Product Sales
ZACKS· 2025-11-05 16:56
Core Insights - Exelixis, Inc. (EXEL) reported better-than-expected results for Q3 2025, with adjusted earnings of 78 cents per share, surpassing the Zacks Consensus Estimate of 68 cents and up from 47 cents in the same quarter last year [1][8] - Net revenues reached $598 million, exceeding the Zacks Consensus Estimate of $589 million and reflecting a year-over-year increase of 10.8% [2][8] - The company's stock has increased by 13.9% year-to-date, outperforming the industry gain of 10.9% [4] Financial Performance - The year-over-year revenue growth was driven by higher product sales, with net product revenues of $542.9 million, up 13.5% year over year [5][8] - Cabometyx (cabozantinib) generated revenues of $540 million, slightly above the Zacks Consensus Estimate of $539 million [6][8] - Collaboration revenues totaled $54.8 million, down 10.8% from $61.5 million in the previous year, primarily due to lower milestone-related revenues [10] Expense Management - Research and development expenses amounted to $199.2 million, down 10.5% year over year, attributed to decreased clinical trial costs [11] - Selling, general, and administrative expenses increased to $123.7 million, up 10.6% year over year, mainly due to higher stock-based compensation [11] Stock Repurchase Program - Exelixis has repurchased $895.3 million of its common stock as of September 30, 2025, under its stock repurchase programs [12][13] - The board authorized an additional $750 million for repurchase before December 31, 2026 [13] Updated Guidance - The company narrowed its 2025 revenue outlook to $2.30-$2.35 billion, with net product revenues estimated between $2.10-$2.15 billion [14] - Research and development expenses are now expected to be in the range of $850-$900 million, while selling, general, and administrative expenses are anticipated to be $500-$525 million [15] Pipeline Developments - Exelixis is developing zanzalintinib, a next-generation oral investigational tyrosine kinase inhibitor, with positive results from the STELLAR-303 study [16][17] - The company plans to submit a new drug application for zanzalintinib in combination with atezolizumab for metastatic colorectal cancer by the end of 2025 [19] - Exelixis has initiated several ongoing phase I studies for its pipeline programs, including XB371, a next-generation tissue factor-targeting antibody-drug conjugate [22] Market Position - Overall performance in the quarter was encouraging, with a beat in both earnings and sales, and initial demand for Cabometyx in the newly approved indication is promising [23]
Prediction: These 2 Under-the-Radar Stocks Could Beat the Market in the Next 5 Years
The Motley Fool· 2025-09-30 08:10
Group 1: Axsome Therapeutics - Axsome Therapeutics is a mid-cap biotech company with three products on the market: Auvelity, Symbravo, and Sunosi, driving strong revenue growth, with a 72% year-over-year increase to $150 million in Q2 [3][4] - The launch of Symbravo in June presents a significant growth opportunity, targeting a market of 39 million migraine patients in the U.S., where over 70% have inadequate responses to current treatments [4][5] - Auvelity shows promise in treating agitation associated with Alzheimer's disease, with a potential market of 7 million patients, and is on track to achieve blockbuster status [5][6] - The company is advancing its pipeline with AXS-12 for narcolepsy and other late-stage trials, positioning itself for continued revenue growth and market outperformance [6] Group 2: Exelixis - Exelixis specializes in oncology, known for its drug Cabometyx, which treats liver and kidney cancers and continues to drive revenue growth despite a reported 11% drop in total revenue to $568.3 million due to lower collaboration revenue [7][8] - Net product revenue for Exelixis increased by 19% year-over-year to $520 million, with Cabometyx expected to maintain strong sales through early 2030, fending off generic competition [8][9] - The company is focused on developing cancer therapies for high unmet needs, with its candidate zanzalintinib showing promise in metastatic colorectal cancer, which could address a significant treatment gap [9][10] - Exelixis has additional candidates in its pipeline, and strong clinical progress alongside Cabometyx's revenue growth is expected to yield strong returns through the end of the decade [10]
Exelixis earns new Buy at Goldman Sachs (EXEL:NASDAQ)
Seeking Alpha· 2025-09-17 17:54
Group 1 - Goldman Sachs initiated coverage of Exelixis (NASDAQ:EXEL) with a Buy recommendation [2] - The target price set by Goldman Sachs for Exelixis is $47 [2] - The recommendation is based on the potential of zanzalintinib to mitigate the upcoming patent cliff for Cabometyx, Exelixis's kidney cancer drug [2]
Can Label Expansion of Cabometyx Fuel Further Growth for EXEL?
ZACKS· 2025-08-26 14:36
Core Insights - Exelixis' lead drug, Cabometyx, has received FDA approval for label expansion to treat adult and pediatric patients aged 12 and older with previously treated, unresectable, locally advanced or metastatic well-differentiated pancreatic and extra-pancreatic neuroendocrine tumors (NET) in March 2025, marking a significant advancement for the company [1][10] Product Overview - Cabometyx is the first and only systemic treatment FDA approved for previously treated NET, applicable regardless of primary tumor site, grade, somatostatin receptor expression, and functional status [2] - The drug is noted as the first broadly applicable new oral small molecule therapy for NET in nine years [2] Market Demand and Performance - Initial uptake for Cabometyx's new indication is strong, capturing 35% of the new patient share for oral therapies in this indication, with demand just over 4% of total demand for cabozantinib in Q2 [3][10] - Exelixis expects Cabometyx to be widely used across various patient and tumor characteristics, including those with NET from the pancreas, GI tract, and lung [5] Regulatory Approvals - In July, Exelixis announced that its partner Ipsen received regulatory approval for Cabometyx for adult patients with unresectable or metastatic well-differentiated extra-pancreatic and pancreatic NET in the EU [4] Competitive Landscape - Cabometyx faces competition from Novartis' Lutathera, which is also used for treating gastroenteropancreatic neuroendocrine tumors (GEP-NETs) [6] - In the renal cell carcinoma (RCC) space, Cabometyx competes with Merck's Keytruda and Inlyta, as well as Merck's Welireg [7][8] Financial Performance - Exelixis shares have gained 13.8% year-to-date, outperforming the industry growth of 4% [9][10] - The company's valuation is considered high, with a price/sales ratio of 4.07x forward sales, above its mean of 3.64x and the biotech industry's 1.58x [11] Earnings Estimates - The bottom-line estimate for 2025 has increased from $2.65 to $2.68, while the estimate for 2026 has decreased from $3.13 to $3.08 over the past 30 days [12]
Exelixis Gains 15.6% YTD: How Should You Play the Stock?
ZACKS· 2025-08-14 14:16
Core Insights - Exelixis (EXEL) has shown strong year-to-date performance with a 15.6% increase in share price, significantly outperforming the industry growth of 2.9% [1] - Despite reaching a 52-week high of $49.62 on June 23, 2025, shares dipped following mixed quarterly results reported on July 28 [1][4] - The company’s lead drug, Cabometyx, continues to perform well in the renal cell carcinoma (RCC) market, supported by strong demand and recent label expansions [5][6] Company Performance - Exelixis' stock has outperformed both the sector and the S&P 500 Index during the year [1] - The company reported a revenue miss in the second quarter, which has affected investor sentiment [8][20] - Cabometyx remains the leading tyrosine kinase inhibitor (TKI) for RCC, with strong sales driven by its combination with Bristol Myers' Opdivo [5][6] Drug Pipeline and Developments - Zanzalintinib, an investigational TKI, has shown positive results in the STELLAR-303 study, meeting a key endpoint for overall survival in metastatic colorectal cancer [10][12] - The company has decided not to proceed with the phase III portion of the STELLAR-305 trial for zanzalintinib due to emerging competition and a focus on larger commercial opportunities [14] - Exelixis is actively expanding its pipeline with three ongoing phase I studies and has received FDA clearance for a new IND application [15] Financial Outlook - Exelixis shares are currently trading at a price/sales ratio of 4.14x forward sales, higher than the biotech industry average of 1.59x [16] - The bottom-line estimate for 2025 has increased slightly from $2.64 to $2.68, while the estimate for 2026 has decreased from $3.13 to $3.09 [17] Competitive Landscape - Cabometyx faces significant competition in the RCC market, particularly from Merck's Keytruda and Pfizer's Inlyta [20][21] - Keytruda is a leading drug in the RCC space, accounting for approximately 50% of Merck's pharmaceutical sales [21]
Will Zanzalintinib Ease Out EXEL's Reliance on Cabometyx for Growth?
ZACKS· 2025-08-13 13:55
Core Insights - Exelixis is developing zanzalintinib, a next-generation oral investigational tyrosine kinase inhibitor (TKI) targeting receptor tyrosine kinases involved in cancer growth, with recent studies showing positive data [1] Study Results - In June 2025, Exelixis announced positive top-line results from the STELLAR-303 study, a phase III trial involving 901 patients with metastatic colorectal cancer, comparing zanzalintinib plus Tecentriq against regorafenib [2] - The STELLAR-303 study met one of its dual primary endpoints, showing a statistically significant improvement in overall survival (OS) for the intent-to-treat population treated with zanzalintinib plus Tecentriq compared to regorafenib [3] - Enrollment for the STELLAR-304 study was completed in May 2025, evaluating zanzalintinib in combination with Opdivo versus sunitinib in advanced non-clear cell renal cell carcinoma [4] - Exelixis has opted not to proceed with the phase III portion of the STELLAR-305 trial based on emerging data and competition in advanced squamous cell carcinoma [5] - The company initiated the phase III STELLAR-311 study in advanced neuroendocrine tumors, comparing zanzalintinib to everolimus [6] Competitive Landscape - The competitive environment for renal cell carcinoma (RCC) is intensifying, with significant competition for Exelixis's lead drug, Cabometyx, from various immunotherapy-TKI combinations [7] - Keytruda, approved for advanced RCC, accounts for approximately 50% of Merck's pharmaceutical sales, highlighting the competitive pressure in the market [10] Financial Performance - Exelixis shares have increased by 14% year-to-date, contrasting with a 0.9% decline in the biotech industry [11] - The company's shares are currently trading at a price/sales ratio of 4.09x forward sales, above its historical mean of 3.64x and the biotech industry's average of 1.59x [13] - The bottom-line estimate for 2025 has risen from $2.64 to $2.68, while the estimate for 2026 has decreased from $3.13 to $3.09 over the past 30 days [14]
Ipsen delivers strong results in the first half of 2025 and upgrades its full-year guidance
Globenewswire· 2025-07-31 05:00
Core Insights - Ipsen reported strong financial results for H1 2025, with total sales reaching €1,819.8 million, a 9.7% increase compared to H1 2024, and 11.4% growth at constant exchange rates (CER) [2][3] - The company achieved a core operating income of €655.8 million, reflecting a 21.9% increase, and a core operating margin of 36.0%, up by 3.6 percentage points [2][3] - Ipsen upgraded its full-year 2025 financial guidance, expecting total sales growth greater than 7.0% at CER, and a core operating margin exceeding 32.0% [3][4] Financial Performance - Total sales for H1 2025 were €1,819.8 million, compared to €1,659.3 million in H1 2024, marking a 9.7% increase [2] - Core operating income rose to €655.8 million from €538.0 million, a growth of 21.9% [2] - Core consolidated net profit increased by 27.3% to €508.3 million, with core earnings per share rising to €6.07 from €4.78 [2] - IFRS operating income was €451.6 million, up 42.1%, with an IFRS operating margin of 24.8%, an increase of 5.7 percentage points [2] Therapeutic Areas Performance - Sales growth was driven by three therapeutic areas: 95.7% in Rare Disease, 9.7% in Neuroscience, and 6.4% in Oncology [3] - The rare liver disease franchise showed particularly strong momentum, contributing significantly to overall sales growth [3] Pipeline and Regulatory Updates - Ipsen received European Commission approval for Cabometyx in advanced neuroendocrine tumors on July 23, 2025, marking the sixth indication for the drug [3][6] - The company is anticipating pivotal study results for fidrisertib in fibrodysplasia ossificans progressiva (FOP) and proof-of-concept data for LANT in aesthetics in the second half of 2025 [3][4] - Recent pipeline developments include the initiation of a Phase II study of LANT in cervical dystonia and the presentation of Iqirvo® data at a major liver congress [5][6] Future Outlook - The company expects a negative impact on Somatuline sales due to increased generic competition in the U.S. and Europe, but remains optimistic about overall growth [4][11] - Ipsen's strategy focuses on external innovation and a commitment to scientific excellence, positioning the company for continued positive impact in the biopharmaceutical sector [4]
2 Highly Ranked Stocks to Consider After Q2 Earnings: CLS, EXEL
ZACKS· 2025-07-30 02:36
Group 1: Celestica (CLS) - Celestica exceeded Q2 earnings expectations, with sales of $2.89 billion, a 21% increase from $2.39 billion a year ago, surpassing estimates by 8% [3] - Q2 earnings soared 53% year-over-year to $1.39 per share, exceeding expectations of $1.24 by 12% [3] - The stock hit an all-time high of $208, spiking 16% in a single trading session, driven by high demand for communications and enterprise hardware products [2][4] - Celestica's stock has increased over 115% in 2025 and more than 135% in the last three months, outperforming broader market indexes [4] Group 2: Exelixis (EXEL) - Exelixis reported Q2 EPS of $0.75, beating expectations of $0.65 by 15%, despite a decline from $0.84 in the previous year [5] - Sales were $568.26 million, missing estimates of $578.91 million and down from $637.18 million in Q2 2024 [5][6] - The stock fell nearly 17% post-earnings, presenting a potential buy-the-dip opportunity, despite reaffirming full-year revenue guidance of $2.25-$2.35 billion [5][7] - Exelixis' stock is down 5% in 2025 but has increased over 80% in the last two years, currently trading under $40 with a forward earnings multiple of 16.6 [9]
Exelixis' Q2 Earnings: Will Cabometyx Sales Drive Growth?
ZACKS· 2025-07-23 15:55
Core Insights - Investors are focused on the performance of the lead drug Cabometyx as Exelixis prepares to report its second-quarter 2025 results on July 28, with sales and earnings estimates at $527 million and 63 cents per share respectively [1][6] Group 1: Earnings Performance - Exelixis has consistently beaten earnings estimates in the past four quarters, with an average surprise of 48.6%, including a 47.62% beat in the last reported quarter [2] - The company's earnings ESP is +2.52%, with the consensus estimate at 63 cents per share and the most accurate estimate at 65 cents [12] Group 2: Revenue Drivers - Revenue generation comes from net product sales, license revenues, and collaboration and service revenues, with net product revenues likely increasing due to higher Cabometyx sales volumes and average net selling prices [3] - The label expansion of Cabometyx for treating pancreatic neuroendocrine tumors (pNET) and extra-pancreatic NET (epNET) is expected to contribute to incremental sales [5][6] Group 3: Drug Performance and Market Position - Cabometyx remains the leading TKI for advanced renal cell carcinoma (RCC) in both front-line and second-line treatment settings, with this trend expected to continue [4] - The FDA's recent approvals for Cabometyx are anticipated to drive additional revenue growth in Q2 [9] Group 4: Share Repurchase and Financial Strategy - The board has authorized a $500 million stock repurchase program, which is expected to enhance the bottom line as the ongoing repurchase program is completed [7] Group 5: Pipeline Developments - Positive results from the late-stage STELLAR-303 study for zanzalintinib, a third-generation oral TKI, are expected to add momentum to the pipeline ahead of earnings [8][9]
Here's Why This $50 Healthcare Stock Could Be the Next $200 Winner
The Motley Fool· 2025-07-20 10:30
Core Viewpoint - Exelixis has shown significant stock price growth over the past decade, with shares increasing from under $10 to approximately $45, indicating strong market performance and potential for further growth [1] Group 1: Company Performance - Exelixis is primarily recognized for its cancer drug, Cabometyx, which was first approved in the U.S. in 2016 for renal cell carcinoma (RCC) and has demonstrated significant improvements in overall survival, progression-free survival, and objective response rate [3] - The company's revenue for the first quarter increased by 30.6% year over year to $555.4 million, with adjusted earnings per share (EPS) more than tripling to $0.62 [4] - Cabometyx has become the most prescribed tyrosine kinase inhibitor among RCC patients and is expanding into other markets, including hepatocellular carcinoma [6] Group 2: Future Growth Potential - Exelixis is preparing for the anticipated generic competition for Cabometyx expected by 2030, indicating proactive strategic planning [7] - The company aims to replicate its past success by developing new cancer medicines that address high unmet needs, with zanzalintinib showing promising phase 3 results for metastatic colorectal cancer (CRC) [8][10] - Zanzalintinib is projected to generate approximately $5 billion in sales, significantly surpassing Cabometyx's current revenue, suggesting strong future growth potential [12] Group 3: Market Position and Strategy - Exelixis is reinforcing its leadership in oncology with several early-stage candidates in development, which could help mitigate the impact of generic competition for Cabometyx [13] - To reach a stock price of $200, Exelixis would need a compound annual growth rate (CAGR) of at least 16.1% over the next decade, a target that, while ambitious, aligns with the company's historical performance [14] - The company is well-positioned to deliver market-beating returns, even if it does not reach the $200 target, indicating a strong investment outlook [15]