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Exelixis (EXEL): A Biotech On Fire – Why Aggressive Investors Should Act Now

Julian WestWednesday, May 14, 2025 11:58 pm ET
14min read

The biotech sector is a realm of high risk and high reward, but few companies today offer the confluence of execution, regulatory momentum, and clinical catalysts that Exelixis (NASDAQ: EXEL) is now delivering. With its Q1 2025 earnings beat, a blockbuster oncology franchise in CABOMETYX®, and a pipeline primed for 2025 readouts, EXEL is primed to outperform for quarters to come. This is a buy signal for investors seeking aggressive growth in a sector starved for near-term winners.

The Q1 Catalyst: CABOMETYX® Drives a 31% Revenue Surge

Exelixis’ first-quarter results were a masterclass in execution. Total revenue jumped to $555.4 million, a 31% year-over-year surge, with CABOMETYX®’s U.S. net product sales surging 36% to $513.3 million. This wasn’t just a one-off beat—management raised full-year guidance by $100 million, now projecting $2.25–2.35 billion in total revenue. The driver? Demand, not luck.

The FDA’s March 2025 approval of CABOMETYX® for previously treated neuroendocrine tumors (NET) has been a game-changer. This indication, the first and only systemic treatment for NET across tumor sites, taps into a $1 billion annual market. By early May, 75% of NET prescribers had already adopted the drug—a near-perfect launch. Exelixis isn’t just capitalizing on this opportunity; it’s rewriting the playbook for oncology commercialization.

NET: A Catalyst with Multiyear Legs

The NET approval isn’t just a one-quarter boost. With median progression-free survival quadrupled in pancreatic NET patients (per the CABINET trial), CABOMETYX® is now the gold-standard treatment for this underserved population. Exelixis isn’t stopping there: the STELLAR-311 trial, starting early 2025, will expand its data into earlier-line NET patients, further solidifying dominance.

But the real kicker is the addressable market. With ~75,000 new NET cases globally each year and CABOMETYX®’s unmatched efficacy, this indication alone could add $300–500 million annually to Exelixis’ top line. Add that to its existing ~44% market share in renal cell carcinoma (RCC)—its original indication—and the math becomes undeniable.

Pipeline Depth: 2025 Is the Year of Clinical Proof

While CABOMETYX® is the current star, Exelixis’ pipeline is loaded with high-value catalysts that could supercharge its growth trajectory:

  1. Zanzalintinib (XL309):
  2. STELLAR-303 (colorectal cancer) and STELLAR-304 (non-clear cell RCC) data expected by year-end.
  3. A potential $2–3 billion peak-seller if approved in multiple tumor types.
  4. Early data from AACR 2025 showed superior progression-free survival vs. standard therapies in solid tumors.

  5. Next-Gen Programs:

  6. XB628 and XB371 advancing to clinical trials in 2025, targeting solid tumors with unmet needs.
  7. STELLAR-305 (head and neck cancer) could fast-track zanzalintinib into pivotal trials by late 2025.

These catalysts aren’t just hypothetical. Exelixis has a 100% FDA approval track record for CABOMETYX® indications to date—a testament to its clinical rigor. With 2025’s data readouts, the company could add multiple indications to its portfolio, creating a virtuous cycle of revenue growth.

Why Buy Now? Near-Term Catalysts and Balance Sheet Strength

  • Valuation: At a forward P/E of ~12x (vs. the sector average of ~20x), EXEL is trading at a discount to its growth prospects.
  • Debt-Free and Aggressive Buybacks: With $1 billion in buybacks authorized and shares reduced by 11% since 2023, EXEL is optimizing for EPS growth.
  • Risk-Adjusted Upside: Even a 20% near-term stock price jump would still leave EXEL undervalued relative to its pipeline’s potential.

Risks? Yes—but the Reward Outweighs Them

Bearish arguments center on competition in RCC (e.g., Pfizer’s axitinib) and clinical trial risks for zanzalintinib. Yet Exelixis’ 44% RCC market share and CABINET’s stellar data suggest a moat against competitors. Meanwhile, zanzalintinib’s preclinical and early-phase data are so strong that even a partial success in late-stage trials could redefine EXEL’s valuation.

Final Call: Buy EXEL Now—This Surge Is Just Beginning

Exelixis isn’t just a biotech—it’s a multi-product oncology powerhouse with execution unmatched in its peer group. The NET approval, Q1 revenue beat, and 2025 pipeline readouts form a catalyst chain that could propel shares to $60–$70+ over the next 12–18 months. For aggressive investors willing to act on near-term visibility and long-term pipeline depth, EXEL is a must-buy in a sector desperate for winners.

The clock is ticking. Exelixis isn’t waiting—neither should you.

Investors should conduct their own due diligence. This analysis is for informational purposes only.

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