Latest news with #Cabometyx
Yahoo
a day ago
- Business
- Yahoo
Exelixis Stock Surges 28% YTD: Should You Buy Now or Sell?
Exelixis EXEL has performed well this year. Shares of the biotech company have gained 28.1% year to date against the industry's decline of 3.5%. The stock has outperformed the sector and the S&P 500 Index in this timeframe. Image Source: Zacks Investment Research The company's upbeat performance can be attributed to its strong quarterly results, raised guidance, label expansion of Cabometyx (cabozantinib) and efforts to increase shareholders' returns. In March, the FDA expanded Cabometyx's label for patients with previously treated advanced neuroendocrine tumors (NET). Let's delve deeper and analyze the company's strengths and weaknesses to make an informed decision on the stock. Exelixis' lead drug Cabometyx maintains its status as the leading tyrosine kinase inhibitor (TKI) for the treatment of renal cell carcinoma (RCC) in both the frontline immuno-oncology (IO) +TKI market and the second-line monotherapy segment. Cabometyx is also approved for use in combination with Bristol Myers' BMY Opdivo in the first-line setting in RCC. Demand has been strong for this combination, boosting sales. BMY's Opdivo is one of the leading IO drugs, and has been approved for various oncology indications. Cabometyx is also approved for the treatment of hepatocellular carcinoma. Given the strong momentum of Cabometyx in the first quarter, EXEL raised its annual guidance for net product revenues and total revenues by $100 million. The recent label expansion of cabozantinib for adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic NET (pNET) and those with previously treated advanced extra-pancreatic NET should further fuel sales. Cabometyx is now the first and only systemic treatment that is FDA approved for previously treated NET regardless of primary tumor site, grade, somatostatin receptor expression and functional status. The pipeline progress has been impressive as well, as Exelixis looks to expand its oncology portfolio beyond Cabometyx. The company is now focused on developing zanzalintinib, a next-generation oral TKI. Results from an expansion cohort of the phase Ib/II STELLAR-001 study evaluating zanzalintinib alone or in combination with Tecentriq (atezolizumab) in patients with previously treated metastatic colorectal cancer (CRC) were encouraging. Results showed that all efficacy parameters, including objective response rate, PFS and overall survival, favored the combination of zanzalintinib plus Tecentriq versus zanzalintinib monotherapy in the overall population as well as in a subgroup of patients without liver metastases. The data support zanzalintinib's ongoing pivotal development in metastatic CRC. Meanwhile, Exelixis collaborated with pharma giant Merck MRK to evaluate zanzalintinib in combination with its blockbuster anti-PD-1 therapy Keytruda (pembrolizumab) in a late-stage study for treating patients with head and neck squamous cell carcinoma (HNSCC). Per the terms of the agreement, Merck is supplying Keytruda for the ongoing, Exelixis-sponsored phase III STELLAR-305 study in previously untreated PD-L1-positive recurrent or metastatic HNSCC. In April, Exelixis presented preclinical data from four pipeline candidates. Data on XL309, XB628 and XB371 were encouraging. Exelixis is on track to submit an investigational new drug application (IND) application for XB371 to the FDA in 2025. The successful development of additional drugs should broaden its portfolio and reduce its dependence on its lead drug, Cabometyx. Exelixis is also making efforts to increase shareholder value through repurchases. In August 2024, the board authorized a stock repurchase program to acquire up to $500 million of the company's common stock before Dec. 31, 2025. In February 2025, another share buyback program for an additional $500 was authorized. Under these programs, as of March 31, 2025, Exelixis repurchased $494.5 million of the company's common stock. From a valuation standpoint, EXEL is expensive. Going by the price/sales ratio, its shares currently trade at 4.75x forward sales, higher than its mean of 3.64x and the biotech industry's 1.69x. Image Source: Zacks Investment Research The bottom-line estimate for 2025 has risen from $2.31 to $2.57, while that for 2026 has increased to $3.02 from $2.85 over the past 30 days. Image Source: Zacks Investment Research Large biotech companies are generally considered safe havens for investors interested in this sector. Exelixis' lead drug, Cabometyx, maintains momentum for the company. The label expansion of Cabometyx should boost its growth. The company's efforts to expand its portfolio are encouraging as well. The successful development of additional drugs should broaden its portfolio and reduce its dependence on its lead drug. The company's efforts to increase shareholder value are impressive and should boost returns. EXEL is a good stock to buy now, considering its good fundamentals and growth prospects. We recommend the stock to investors as we believe there is more room for growth. EXEL currently carries a Zacks Rank #2 (Buy). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Bristol Myers Squibb Company (BMY) : Free Stock Analysis Report Merck & Co., Inc. (MRK) : Free Stock Analysis Report Exelixis, Inc. (EXEL) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
14-05-2025
- Business
- Yahoo
EXEL Q1 Earnings Beat, 2025 Sales View Up as Cabometyx Drives Top Line
Exelixis, Inc. EXEL reported better-than-expected first-quarter 2025 results. EXEL recorded adjusted earnings of 62 cents per share, which beat the Zacks Consensus Estimate of 42 cents. The company registered adjusted earnings of 17 cents per share in the year-ago quarter. Higher revenues mainly drove the outperformance. Adjusted earnings exclude the impact of stock-based compensation expenses. Including stock-based compensation expense, earnings were 55 cents per share in the reported quarter compared with 12 cents in the year-ago quarter. Net revenues were $555.4 million, which beat the Zacks Consensus Estimate of $503 million. The top line surged 31% year over year. Net product revenues were $513.3 million, up 36% year over year. This rise was primarily driven by increased sales volume and average net selling price of Exelixis' lead drug, Cabometyx. Cabometyx (cabozantinib) generated revenues of $510.9 million, which beat the Zacks Consensus Estimate of $433.7 million and our model estimate of $457.3 million. The drug is approved for advanced renal cell carcinoma and previously treated hepatocellular carcinoma. Cometriq (cabozantinib capsules) generated $2.4 million in net product revenues for treating medullary thyroid cancer. Collaboration revenues, comprising license and collaboration services revenues, totaled $42.2 million, down 10% from $46.7 million recorded in the year-ago quarter. This decrease in collaboration revenues was mainly due to lower royalty revenues for the sales of cabozantinib outside of the United States, generated by collaboration partners (Ipsen Pharma and Takeda). Exelixis' shares have risen 11% year to date against the industry's decline of 6.4%. Image Source: Zacks Investment Research Research and development expenses (including stock-based compensation) amounted to $212.2 million, down 7% year over year. The decline was primarily due to reduced license and other collaboration costs and lower clinical study costs, partially offset by higher personnel-related expenses. Selling, general and administrative expenses totaled $137.2 million, up 20% year over year. This uptick was primarily related to increases in personnel, corporate and marketing expenses. In August 2024, Exelixis announced that the board of directors authorized the repurchase of up to $500 million of its common stock. Subsequently, in February 2025, EXEL's board of directors authorized the repurchase of up to an additional $500 million of its common stock. As of March 31, 2025, Exelixis repurchased $494.5 million of its common stock. Exelixis has revised upwards its sales guidance for 2025. Total revenues are now expected to be between $2.25 billion and $2.35 billion compared with the previously guided range of $2.15-$2.25 billion. Net product revenues are now estimated to be in the range of $2.05-$2.15 billion compared with the previously guided range of $1.95-$2.05 billion. The current guidance includes the impact of a 2.8% price increase of Cabometyx in the United States, effective Jan. 1, 2025. Research and Development expenses are expected to be in the range of $925-$975 million. Selling, general and administrative expenses are anticipated to be in the $475-$525 million range. The effective tax rate for the company is anticipated in the 21-23% range for 2025. In March 2025, Exelixis announced the FDA approval for the label expansion of Cabometyx for the treatment of adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic and extra-pancreatic neuroendocrine tumors. Consequently, Cabometyx is now the first and only systemic treatment that is FDA-approved for previously treated neuroendocrine tumors regardless of primary tumor site, grade, somatostatin receptor expression and functional status. The company is developing zanzalintinib, a next-generation oral TKI. In January 2025, EXEL presented results from an expansion cohort of the phase Ib/II STELLAR-001 trial evaluating zanzalintinib alone or in combination with Tecentriq (atezolizumab) in patients with previously treated metastatic colorectal cancer. Results showed that all efficacy parameters, including objective response rate, progression-free survival and overall survival, favored the combination of zanzalintinib plus Tecentriq versus zanzalintinib monotherapy in the overall population as well as in a subgroup of patients without liver metastases. Exelixis, Inc. price-consensus-eps-surprise-chart | Exelixis, Inc. Quote Exelixis currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Bayer BAYRY, Editas Medicine EDIT and Allogene Therapeutics ALLO, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. In the past 60 days, estimates for Bayer's earnings per share have increased from $1.17 to $1.23 for 2025. During the same time, earnings per share have increased from $1.27 to $1.31 for 2026. Year to date, shares of Bayer have gained 42%. BAYRY's earnings matched estimates in two of the trailing three quarters while missing the same on the remaining occasion, the average negative surprise being 19.61%. In the past 60 days, estimates for Editas Medicine's loss per share have narrowed from $1.57 to $1.53 for 2025. During the same time, loss per share estimates for 2026 have widened from $1.22 to $1.25. Year to date, shares of EDIT have gained 18.1%. EDIT's earnings beat estimates in two of the trailing four quarters while missing the same on the other two occasions, delivering an average negative surprise of 10.72%. In the past 60 days, estimates for Allogene Therapeutics' loss per share have narrowed from $1.26 to $1.15 for 2025. During the same time, loss per share estimates for 2026 have narrowed from $1.34 to $1.17. Year to date, shares of ALLO have lost 46.9%. ALLO's earnings beat estimates in three of the trailing four quarters and matched the same on the remaining occasion, delivering an average surprise of 11.70%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Bayer Aktiengesellschaft (BAYRY) : Free Stock Analysis Report Exelixis, Inc. (EXEL) : Free Stock Analysis Report Editas Medicine, Inc. (EDIT) : Free Stock Analysis Report Allogene Therapeutics, Inc. (ALLO) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
14-05-2025
- Business
- Yahoo
Why Exelixis Stock Is Skyrocketing Today
Exelixis handily beat Q1 revenue and earnings estimates. The drugmaker also increased its full-year revenue guidance by $100 million. Exelixis could have more catalysts on the way later this year. 10 stocks we like better than Exelixis › Shares of Exelixis (NASDAQ: EXEL) were skyrocketing 18.5% higher at 11:05 a.m. ET on Wednesday. The huge gain came after the drugmaker announced its 2025 first-quarter results Tuesday evening. Exelixis reported Q1 revenue of $555.4 million, up 30.6% year over year. This result handily topped the consensus revenue estimate of $503 million. The company posted net income of $159.6 million, or $0.55 per diluted share, based on generally accepted accounting principles (GAAP). Non-GAAP earnings were $179.6 million, or $0.62 per diluted share. This reflected a significant improvement from non-GAAP earnings of $52 million, or $0.17 per diluted share, in the prior-year period. It also blew past Wall Street's average Q1 adjusted earnings estimate of $0.42 per share. Investors like it anytime a company beats top- and bottom-line quarterly estimates, as Exelixis did in Q1. However, what they really loved in this case was Exelixis' full-year guidance. The company raised its full-year revenue outlook to a range of $2.25 billion to $2.35 billion from the previous forecast of between $2.15 billion and $2.25 billion. This $100 million guidance increase was the result of accelerating demand for Exelixis' flagship cancer drug, Cabometyx. Don't be surprised by further guidance hikes later this year. CEO Michael Morrissey said in the Q1 earnings press release that the company's team quickly shifted into action to launch Cabometyx in the advanced neuroendocrine tumors (NET) indication "within hours of receiving U.S. regulatory approval in late March." He added, "We are very pleased with the initial reception and plan to provide further updates to our 2025 financial guidance as we build momentum on the NET launch and gain further clarity on additional revenue opportunities for 2025." Exelixis could have more good news on the way as well. The company expects to report results from pivotal clinical studies evaluating zanzalintinib in treating colorectal cancer and non-clear cell renal cell carcinoma in the second half of 2025. With these near-term potential positive catalysts and continued strength for Cabometyx, I think Exelixis remains a good biotech stock for aggressive investors to buy. Before you buy stock in Exelixis, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the for investors to buy now… and Exelixis wasn't one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you'd have $613,951!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you'd have $796,353!* Now, it's worth noting Stock Advisor's total average return is 948% — a market-crushing outperformance compared to 170% for the S&P 500. Don't miss out on the latest top 10 list, available when you join . See the 10 stocks » *Stock Advisor returns as of May 12, 2025 Keith Speights has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends Exelixis. The Motley Fool has a disclosure policy. Why Exelixis Stock Is Skyrocketing Today was originally published by The Motley Fool
Globe and Mail
26-04-2025
- Business
- Globe and Mail
Exelixis' Q1 Earnings: Will Cabometyx Maintain Momentum?
Investors will focus on lead drug Cabometyx's performance when Exelixis EXEL reports first-quarter 2025 results shortly. The Zacks Consensus Estimate for sales and earnings is pegged at $502.8 million and 42 cents per share, respectively. (Find the latest EPS estimates and surprises on Zacks Earnings Calendar.) Exelixis' Earnings Surprise History Exelixis beat on earnings in three of the trailing four quarters and missed in the remaining one, the average surprise being 26.87%. In the last reported quarter, the company beat on earnings by 7.84%. Factors at Play in Q1 Exelixis generates revenues from net product sales, license revenues and collaboration and service revenues. Net product revenues have likely increased in the first quarter, driven by a rise in Cabometyx sales volumes and average net selling price. Cabometyx is approved for advanced renal cell carcinoma (RCC) and previously treated hepatocellular carcinoma. The drug maintains its status as the leading TKI for RCC, both in the front-line IO+TKI market and the second-line monotherapy segment. The trend is likely to have continued in the first quarter. The Zacks Consensus Estimate for sales of the drug is pegged at $434 million and our model estimate for the same is pinned at $457.3 million. Collaboration revenues increased in the previous quarter on higher royalty revenues for the sales of cabozantinib outside of the United States generated by collaboration partners, Ipsen Pharma SAS and Takeda Pharmaceutical Company Limited. The trend is likely to have continued in the to-be-reported quarter. Last month, the FDA approved the label expansion of Cabometyx for the treatment of adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors (pNET). Simultaneously, the drug was approved for adult and pediatric patients (12 years of age and older) with previously treated, unresectable, locally advanced or metastatic, well-differentiated extra-pancreatic NET (epNET). Additional updates on the same are expected. The board recently authorized the repurchase of up to an additional $500 million of the company's common stock before Dec. 31, 2025. Exelixis plans to complete the currently ongoing $500 million stock repurchase program (announced in August 2024) in the second quarter of 2025 and commence repurchases under the newly authorized program thereafter. The bottom line has likely gained from the ongoing share expenses might have increased due to costs associated with the broader portfolio. What Our Model Predicts for EXEL Our proven model predicts an earnings beat for EXEL this time around. The combination of a positive Earnings ESP and a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold) increases the odds of an earnings beat. This is the case here, as you will see below. Earnings ESP: Earnings ESP for Exelixis is +7.14% as the Zacks Consensus Estimate is pegged at 42 cents per share, while the Most Accurate Estimate is pinned at 45 cents per share. You can uncover the best stocks to buy or sell before they're reported with our Earnings ESP Filter. Zacks Rank: The company currently carries a Zacks Rank #3. Exelixis Price Performance The company's shares have gained 11.4% year to date against the industry 's decline of 3.7%. Stocks to Consider Here are some stocks you may want to consider, as our model shows that these have the right combination of elements to post an earnings beat this reporting cycle. argenx ARGX has an Earnings ESP of +10.92% and a Zacks Rank #2 at present. You can see the complete list of today's Zacks #1 Rank stocks here. ARGX beat on earnings in two of the last four quarters and missed in the other two, delivering an average surprise of 345.11%. Vertex Pharmaceuticals VRTX has an Earnings ESP of +0.40% and a Zacks Rank #3 at present. VRTX beat on earnings in two of the trailing four quarters and missed in the remaining two, the average surprise being 2.58%. The company will report first-quarter results on May 5, 2025. AstraZeneca AZN has an Earnings ESP of +2.73% and a Zacks Rank #3 at present. AZN is scheduled to release first-quarter results on April 29, 2025. AstraZeneca beat on earnings in three of the trailing four quarters and missed in the remaining one, the average surprise being 3.16%. Only $1 to See All Zacks' Buys and Sells We're not kidding. Several years ago, we shocked our members by offering them 30-day access to all our picks for the total sum of only $1. No obligation to spend another cent. Thousands have taken advantage of this opportunity. Thousands did not - they thought there must be a catch. Yes, we do have a reason. We want you to get acquainted with our portfolio services like Surprise Trader, Stocks Under $10, Technology Innovators, and more, that closed 256 positions with double- and triple-digit gains in 2024 alone. See Stocks Now >> Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report AstraZeneca PLC (AZN): Free Stock Analysis Report Vertex Pharmaceuticals Incorporated (VRTX): Free Stock Analysis Report Exelixis, Inc. (EXEL): Free Stock Analysis Report argenex SE (ARGX): Free Stock Analysis Report
Yahoo
04-04-2025
- Business
- Yahoo
The Smartest Biotech Stocks to Buy With $50
One of the great things about equity markets is that you don't need a fortune to get started. Though strong companies that perform well tend to attract plenty of attention that bids up their share prices, it's possible to buy shares of quality stocks with $50 -- or less. Here are two great examples in the biotech industry: Viking Therapeutics (NASDAQ: VKTX) and Exelixis (NASDAQ: EXEL). These two drugmakers could generate outsized returns to investors who initiate positions now. Viking Therapeutics, a mid-cap biotech, is looking to make waves in the fast-growing market for weight management medicines. Last year, it reported positive phase 2 results for the subcutaneous formulation of its leading candidate, VK2735. It will move forward with phase 3 studies for this product soon. Meanwhile, Viking Therapeutics is also developing an oral version of its anti-obesity therapy; this formulation recently started phase 2 studies after performing well in a phase 1 clinical trial last year. The potential for Viking could be large, considering the current weight management leaders' success. Viking's candidate may not need to generate the kind of sales that Wegovy and Zepbound do. However, reaching blockbuster status would be a significant accomplishment for the smaller company. And although the weight loss field is getting crowded, few companies not named Eli Lilly or Novo Nordisk have posted mid-stage results that rival those for VK2735. Furthermore, Viking has several other exciting candidates. Its investigational medicine for metabolic dysfunction-associated steatohepatitis (MASH), VK2809, also performed well in mid-stage studies. Viking is working on yet another potential weight loss candidate that's still in preclinical studies, showing that the company isn't putting all its eggs in one basket. Viking Therapeutics is a bit risky since it still doesn't have a single approved product, but it's shown innovative qualities and its shares could skyrocket in the long run if its mid-stage programs pan out. If you're an investor comfortable with volatility, it might be well worth it to initiate a small position in the stock at a price of about $25 per share. The oncology market is one of the industry's largest and most competitive -- the most prominent pharmaceutical companies typically dominate it. However, Exelixis, a relatively small biotech compared to the leaders, is a successful cancer-focused drugmaker. Recent events once again highlight why. On March 26, it announced that Cabometyx, its best-selling product, earned a label expansion in the U.S. in treating advanced neuroendocrine tumors. Cabometyx has been Exelixis' most significant growth driver for a while, and it continues to grind out new indications that help the biotech generate growing revenue and profits. In 2024, Exelixis' top line increased by a healthy 18.5% year over year to $2.2 billion. The company's adjusted net earnings per share grew by 22% year over year to $2. Importantly, Exelixis put a significant risk to bed last year. The company had been fighting a legal battle over the potential launch of a Cabometyx generic by MSN Laboratories, a privately held biotech. Exelixis won the battle and won't have to worry about MSN's generics until 2030. Until then, new and existing indications for Cabometyx will keep revenue going in the right direction -- it remains the top-prescribed medicine of its kind in renal cell carcinoma, by far the most common type of kidney cancer. And it's still undergoing clinical trials, so more label expansions might be coming. Meanwhile, Exelixis is developing newer medicines, hoping to find another "pipeline in a drug" like Cabometyx. There is a high unmet need in colorectal cancer, since the disease has a low five-year survival rate once it metastasizes. Exelixis is looking to fill this need with zanzalintinib, which is undergoing phase 3 studies in advanced colorectal cancer, among other targets. It also has other programs in early-stage studies. Between the continuing performance of Cabometyx, Exelixis' pipeline, and the company's ability to navigate the competitive oncology market successfully, you could buy and hold this stock for a long time -- and its shares are trading hands for just under $37 each. Ever feel like you missed the boat in buying the most successful stocks? Then you'll want to hear this. On rare occasions, our expert team of analysts issues a 'Double Down' stock recommendation for companies that they think are about to pop. If you're worried you've already missed your chance to invest, now is the best time to buy before it's too late. And the numbers speak for themselves: Nvidia: if you invested $1,000 when we doubled down in 2009, you'd have $285,647!* Apple: if you invested $1,000 when we doubled down in 2008, you'd have $42,315!* Netflix: if you invested $1,000 when we doubled down in 2004, you'd have $500,667!* Right now, we're issuing 'Double Down' alerts for three incredible companies, and there may not be another chance like this anytime soon.*Stock Advisor returns as of April 1, 2025 Prosper Junior Bakiny has positions in Eli Lilly, Exelixis, Novo Nordisk, and Viking Therapeutics. The Motley Fool has positions in and recommends Exelixis. The Motley Fool recommends Novo Nordisk and Viking Therapeutics. The Motley Fool has a disclosure policy. The Smartest Biotech Stocks to Buy With $50 was originally published by The Motley Fool Sign in to access your portfolio
