Exelixis, Inc. · NASDAQ:EXEL
Exelixis — Q1 2025 Earnings Presentation
45 slides from Exelixis's earnings presentation, May 13, 2025
Slide 1: First Quarter 2025 Financial Results
TUESDAY, MAY 13, 2025 First Quarter 2025 Financial Results Nasdaq: EXEL
Slide 2: Today's Agenda
Today’s Agenda Introduction Susan Hubbard EVP, Public Affairs and Investor Relations First Quarter 2025 Highlights Michael M. Morrissey, Ph.D. President and CEO Financial Results & Guidance Chris Senner EVP and CFO Commercial Update PJ Haley EVP, Commercial Development Update Amy Peterson, M.D. EVP,
Slide 3: Forward-Looking Statements
Forward-Looking Statements This presentation, including any oral presentation accompanying it, contains forward-looking statements, including, without limitation, statements related to: Exelixis’ plans to build a multi-product, multi- franchise oncology business, including potential market opportuni
Slide 4: First Quarter 2025 Highlights
First Quarter 2025 Highlights Michael M. Morrissey, Ph.D. President and CEO 4
Slide 5: Strong Q1 2025 Highlighted by Significant Progress and Momentum
Strong Q1 2025 Highlighted by Significant Progress and Momentum Accelerating growth of U.S. cabozantinib franchise • Strong performance of U.S. business with continued growth in demand, new patient starts and revenues • 1Q 2025 U.S. NPR grew 36% YoY to $513.3M vs $378.5M (1Q 2024) • Increasing FY 20
Slide 6: Strong Q1 2025 Highlighted by Significant Progress and Momentum
Strong Q1 2025 Highlighted by Significant Progress and Momentum Zanzalintinib takes center stage as next oncology franchise opportunity • Zanzalintinib anticipated pivotal data milestones in 2H’25: TLR for STELLAR-303/CRC and STELLAR-304/nccRCC, Phase 3 “go/no-go” for STELLAR-305/HNSCC (all pending
Slide 7: Financial Results & Guidance
Financial Results & Guidance Chris Senner EVP and CFO 7
Slide 8: Q1'25 Total Revenues
Q1’25 Total Revenues (See press release at www.exelixis.com for full details) $700 Cabozantinib Net Product Revenues Collaboration Revenues 637.2 $600 566.8 555.4 Q1’25 Notes 539.5 51.5 199.6 42.2 $500 61.5 • $513.3M in cabozantinib net product 425.2 revenues (In Millions) $400 46.7 • Q1’25 collabor
Slide 9: Q1'25 R&D Expenses
Q1’25 R&D Expenses (See press release at www.exelixis.com for full details) All Other R&D Expenses License and Other Collaboration Costs* Stock-Based Compensation $300 249.0 Q1’25 Notes $250 227.7 8.8 222.6 21.9 3.9 211.1 8.8 212.2 • GAAP R&D expenses of $212.2M 22.8 9.2 9.5 $200 5.8 18.7 5.3 • Decr
Slide 10: Q1'25 SG&A Expenses
Q1’25 SG&A Expenses (See press release at www.exelixis.com for full details) $160 All Other SG&A Expenses Stock-Based Compensation 137.2 $140 132.0 134.3 Q1’25 Notes 17.5 16.4 $120 114.0 16.2 111.8 • GAAP SG&A expenses of $137.2M 15.2 14.3 $100 (In Millions) • Increase in GAAP SG&A expenses vs. $80
Slide 11: Q1'25 Net Income
Q1’25 Net Income (See press release at www.exelixis.com for full details) GAAP Net Income Non-GAAP Net Income $300 $250 245.6 Q1’25 Notes 226.1 • GAAP net income of $159.6M $200 179.6 • Increase in GAAP net income vs. Q4’24 (In Millions) 160.3 159.6 primarily due to lower operating $150 135.7 139.9
Slide 12: Q1'25 Diluted Earnings Per Share
Q1’25 Diluted Earnings Per Share (See press release at www.exelixis.com for full details) $1.00 GAAP diluted EPS Non-GAAP diluted EPS $0.90 0.84 Q1’25 Notes $0.80 0.77 $0.70 • GAAP diluted earnings per share of $0.55 0.62 $0.60 0.55 • Increase in GAAP EPS vs. Q4’24 primarily (In Dollars) 0.55 due to
Slide 13: GAAP Financial Highlights: Q1'25
GAAP Financial Highlights: Q1’25 (in millions, except per share amounts) Q1’24 Q4'24 Q1’25 YoY Delta QoQ Delta Total revenues $425.2 M $566.8 M $555.4 M +31% -2% Cost of goods sold $21.3 M $20.0 M $19.2 M -10% -4% R&D expenses $227.7 M $249.0 M $212.2 M -7% -15% SG&A expenses $114.0 M $134.3 M $137.
Slide 14: 2025 Stock Repurchase Program Activity
2025 Stock Repurchase Program Activity (in millions, except per share amounts) Amount Shares Average Purchase Price Repurchased Repurchased per Share Q1 2025 $288.8 8.061 $35.83 $500M stock repurchase program authorized in August 2024, with $5.5M remaining as of the end of Q1 2025. Additional $500M
Slide 15: Fiscal Year 2025 Financial Guidance
Fiscal Year 2025 Financial Guidance* Current Guidance Previous Guidance (Provided May 13, 2025) (Provided January 12, 2025) Total Revenues $2.25B - $2.35B $2.15B - $2.25B Net Product Revenues $2.05B - $2.15B $1.95B - $2.05B Cost of Goods Sold 4% - 5% of net product revenues 4% - 5% of net product re
Slide 16: Commercial Update
Commercial Update PJ Haley EVP, Commercial 16
Slide 17: CABOMETYX: Q1 2025 Performance
CABOMETYX: Q1 2025 Performance Strong execution and momentum in Q1’25 • $513M in U.S. cabozantinib franchise net product revenues • Increasing demand and new patient starts driven by CABOMETYX + nivolumab in 1L RCC The #1 prescribed TKI+IO combination • CABOMETYX + nivolumab remains the most prescri
Slide 18: CABOMETYX Business Summary - #1 TKI in RCC
CABOMETYX Business Summary - #1 TKI in RCC CABOMETYX continues to lead TRx market TRx Market Share +18% YoY with ~44% share in Q1’25 TRx • Broad uptake in the 1L RCC setting across clinical Growth risk groups and practice settings 40% 36% $376M* 44% $511M* • Prescriber experience continues to be pos
Slide 19: CABOMETYX Business Summary - #1 TKI in RCC
CABOMETYX Business Summary - #1 TKI in RCC CABOMETYX continues to lead NRx market NRx Market Share with ~43% share in Q1’25 +27% YoY NRx • Broad uptake in the 1L RCC setting across clinical Growth risk groups and practice settings 43% • Prescriber experience continues to be positive 36% 39% 38% 36%
Slide 20: NET Represents a Compelling Opportunity for CABOMETYX
NET Represents a Compelling Opportunity for CABOMETYX Current 2L+ NET Treatment Landscape Potential Opportunity in NET** • Small molecule NET market valued ~$1B in 2025 • High level of unmet need and desire for treatment options that ~20% can address a broad NET patient population provide a compelli
Slide 21: CABINET Study's Diverse Patient Population Led to Broad NCCN Recommendation and FDA Approved Indication
CABINET Study’s Diverse Patient Population Led to Broad NCCN Recommendation and FDA Approved Indication CABINET Study NCCN Guideline Version 1, 2025 Broad Patient Inclusion Neuroendocrine and Adrenal Tumors CABOMETYX is widely preferred or recommended for Pancreatic, • Disease Site of Origin GI, Lun
Slide 22: CABOMETYX NET Promotion Began Immediately Upon FDA Approval
CABOMETYX NET Promotion Began Immediately Upon FDA Approval NOW APPROVED for the treatment of previously treated well-differentiated NET (age >= 12 ) 1st and only FDA-approved treatment for previously treated NET regardless of site of origin and functional status Quadrupled median PFS in pNET Double
Slide 23: Strong Start to NET Launch Execution
Strong Start to NET Launch Execution Personal promotional efforts rapidly Observing increased NET patient resulted in over 75% reach within engagement via BE CONNECTED NET prescriber universe patient support programs Comprehensive non-personal Broad HCP community promotional deployments engagement a
Slide 24: Opportunity to Establish a Leadership Position in NET Similar to RCC
Opportunity to Establish a Leadership Position in NET Similar to RCC Significant Potential for Exelixis in NET Commercial team is executing NET launch with urgency • Launch goal is to rapidly establish CABOMETYX as the small molecule market leader in NET • HCPs are responding positively to NET launc
Slide 25: Development Update
Development Update Amy Peterson, M.D. EVP, Product Development and Medical Affairs and CMO 25
Slide 26: Phase 3 CABINET Trial: PFS and FDA Approval of Cabozantinib for NET
U.S. FDA Approval of Cabozantinib sNDA for NET Ahead of PDUFA Date pNET Phase 3 CABINET Trial PFS HR = 0.22 (0.12, 0.41) Progression Free Survival • Study demonstrated quadrupled median PFS in pNET Probability of and doubled median PFS in epNET 13.8mo mPFS • Subgroup analyses suggest benefits across
Slide 27: Zanzalintinib Development Vision: The VEGFR TKI of Choice
Zanzalintinib Development Vision: The VEGFR TKI of Choice for Monotherapy and Combinations Zanzalintinib Characteristics • Potent inhibition of multiple kinases TKI including MET, VEGFR, AXL and MER combination of choice • Optimized pharmacokinetic profile • Steady state achieved faster than Potenti
Slide 28: STELLAR-303: Pivotal Study of Zanzalintinib + Atezolizumab in 3L+ CRC
STELLAR-303: Pivotal Study of Zanzalintinib + Atezolizumab in 3L+ CRC Exelixis-sponsored Trial with Atezolizumab Supplied by Genentech/Roche STELLAR-303 (Phase 3) • Study of zanzalintinib + atezolizumab in patients with MSS/MSI-low metastatic CRC refractory or intolerant to Experimental Arm chemothe
Slide 29: STELLAR-304: Pivotal Study of Zanzalintinib + Nivolumab in 1L nccRCC
STELLAR-304: Pivotal Study of Zanzalintinib + Nivolumab in 1L nccRCC Exelixis-sponsored Trial with Nivolumab Supplied by Bristol Myers Squibb STELLAR-304 (Phase 3) • A study of zanzalintinib + nivolumab vs. sunitinib Experimental Arm in 1L unresectable, advanced or metastatic zanzalintinib + nivolum
Slide 30: STELLAR-305: Pivotal Study of Zanzalintinib + Pembrolizumab in 1L PD-L1+ HNSCC
STELLAR-305: Pivotal Study of Zanzalintinib + Pembrolizumab in 1L PD-L1+ HNSCC Exelixis-sponsored Trial with Pembrolizumab Supplied by Merck STELLAR-305 (Phase 2/3) • A study of zanzalintinib + pembrolizumab vs. Experimental Arm pembrolizumab alone in R/M HNSCC incurable zanzalintinib + pembrolizum
Slide 31: Current Zanzalintinib Pivotal Development Program
Current Zanzalintinib Pivotal Development Program Six Ongoing or Planned Zanzalintinib Pivotal Studies in 2025 Gastrointestinal Cancers Genitourinary Cancers Head & Neck 303 311 304 Merck RCC Studies 305 Setting 3L+, non-MSI high, Advanced NET 1L, nccRCC: papillary, PD-L1+ Zanzalintinib Zanzalintini
Slide 32: Numerous Presentations for Cabozantinib and Zanzalintinib at ASCO'25
Numerous Presentations for Cabozantinib and Zanzalintinib at ASCO’25 Select Cabozantinib-related Abstracts Zanzalintinib Abstracts 4020 - Health-related quality of life (HRQOL) in the phase 3 trial of cabozantinib vs placebo 4515 - Zanzalintinib (zanza) + nivolumab (nivo) ± relatlimab (rela) in for
Slide 33: Pipeline & Discovery Update
Pipeline & Discovery Update Dana T. Aftab, Ph.D. EVP, Discovery and Translational Research and CSO 33
Slide 34: Diversified Pipeline of Potentially Best-in-class and/or First-in-class Molecules
Diversified Pipeline of Potentially Best-in-class and/or First-in-class Molecules Could Expand Our Patient Impact and Drive Long-term Growth Select Exelixis Early-Stage Pipeline Programs • 3 internal clinical programs with best- and/or first-in-class potential are in Best-in- First-in- Phase 1 devel
Slide 35: Closing
Closing Michael M. Morrissey, Ph.D. President and CEO 35
Slide 36: Key 2025 Corporate Objectives
Key 2025 Corporate Objectives Execute on business goals and maintain strong financial performance • Guiding to additional growth in 2025, potential upside with NET • Continue prudent expense management • Complete ongoing 2024-2025 stock repurchase programs, totaling $1 billion Pursue label expansion
Slide 37: Q&A Session
Q&A Session 37
Slide 38: First Quarter 2025 Financial Results
TUESDAY, MAY 13, 2025 First Quarter 2025 Financial Results Nasdaq: EXEL
Slide 39: Financial Appendix
Financial Appendix 39
Slide 40: Non-GAAP Financial Highlights: Q1'25
Non-GAAP Financial Highlights: Q1’25 (in millions, except per share amounts) Q1’24 Q4’24 Q1’25 YoY Delta QoQ Delta Total revenues $425.2 M $566.8 M $555.4 M +31% -2% Cost of goods sold $21.3 M $20.0 M $19.2 M -10% -4% R&D expenses (a)(b) $223.8 M $240.2 M $202.7 M -9% -16% SG&A expenses (a)(b) $98.8
Slide 41: Q1'25 Ipsen Royalties
Q1’25 Ipsen Royalties Ipsen ex-US and ex-Japan Cabozantinib Franchise Net Product Revenues* Ipsen Royalty to Exelixis $180 168.1 166.2 Q1’25 Notes 159.5 160.0 $160 154.5 $140 • Q1’25 Ipsen ex-US and ex-Japan cabozantinib franchise net product (In Millions) $120 revenues of $154.5M $100 • Q1’25 Ipsen
Slide 42: Q1'25 Diluted Weighted Average Shares Outstanding
Q1’25 Diluted Weighted Average Shares Outstanding 350 Weighted Avg Shares Outstanding - Diluted 325 305.5 300 294.0 291.5 293.5 288.2 Q1’25 Notes 275 250 225 • Net decrease in diluted weighted average shares outstanding since Q1’24 due to (In Millions) 200 175 our share repurchase programs 150 125 1
Slide 43: GAAP to Non-GAAP Reconciliation
GAAP to Non-GAAP Reconciliation (in millions, except per share amounts) Non-GAAP Financial Measures To supplement Exelixis’ financial results presented in accordance with U.S. Generally Accepted Accounting Principles (GAAP), Exelixis uses certain non-GAAP financial measures in this presentation and
Slide 44: GAAP to Non-GAAP Reconciliation (continued)
GAAP to Non-GAAP Reconciliation (continued) (in millions, except per share amounts) Q1'24 Q2'24 Q3'24 Q4'24 Q1'25 Net Income reconciliation: GAAP Net Income $ 37.3 $ 226.1 $ 118.0 $ 139.9 $ 159.6 (1) Stock-based compensation - Research and development 3.9 9.2 8.8 8.8 9.5 Stock-based compensation - S
Slide 45: First Quarter 2025 Financial Results
TUESDAY, MAY 13, 2025 First Quarter 2025 Financial Results Nasdaq: EXEL