Exelixis, Inc. · NASDAQ:EXEL
Exelixis — Q1 2020 Earnings Presentation
38 slides from Exelixis's earnings presentation, May 5, 2020
Slide 1: First Quarter 2020 Financial Results
First Quarter 2020 Financial Results Tuesday, May 5, 2020 Nasdaq: EXEL
Slide 2: Today's Agenda
Today’s Agenda Introduction Susan Hubbard EVP, Public Affairs and Investor Relations Overview Michael M. Morrissey, Ph.D. President & CEO Development Update Gisela Schwab, M.D. President, Product Development and Medical Affairs & CMO Financial Results & Guidance Chris Senner EVP & CFO Commercial Upd
Slide 3: Safe Harbor Statement
Safe Harbor Statement This presentation, including any oral presentation accompanying it, contains forward-looking statements, including, without limitation, statements related to: Exelixis’ expectations with respect to clinical trial initiation, enrollment and top-line data readouts in 2020, and po
Slide 4: Overview
Overview Michael M. Morrissey, Ph.D. President and CEO 3
Slide 5: Effective Organizational Response to COVID-19
Effective Organizational Response to COVID-19 Employee Health ▪ Enacted work-from-home policy ahead of CA shelter in place order and Safety ▪ Converted sales team field activities to virtual touchpoints ▪ Patient access to our medicines remains a top priority both in the Business Continuity commerci
Slide 6: Strong Start to 2020, Focused on Execution and Achievement
Strong Start to 2020, Focused on Execution and Achievement Clinical execution around cabozantinib in 2020-2021 ▪ On track to have 12 label-enabling trials enrolling by year-end ▪ 6 top-line data readouts anticipated throughout 2020 ▪ 4 new potential indications in 2021 Continued pipeline progress ▪
Slide 7: Clinical Development Update
Clinical Development Update Gisela Schwab, M.D. President, Product Development and Medical Affairs & CMO 6
Slide 8: CheckMate -9ER: Phase 3 Pivotal Trial in First-line RCC
CheckMate -9ER: Phase 3 Pivotal Trial of Cabozantinib + Nivolumab in First-line RCC (Sponsored by BMS, with co-funding from Exelixis, Ipsen and Takeda) CheckMate -9ER (Ph 3) ARM Cabozantinib 40 mg A + Nivolumab ▪ A study of cabo + nivo vs sunitinib in previously untreated advanced or metastatic RCC
Slide 9: CheckMate -9ER: Positive Topline Results Announced
CheckMate -9ER: Positive Topline Results Announced, Meeting Primary and Key Secondary Endpoints with Favorable Safety Profile Primary Endpoint: Progression-free Survival Cabozantinib + nivolumab significantly reduced risk of disease progression or death vs sunitinib (HR = 0.51, p<0.0001) Secondary E
Slide 10: Cabozantinib May Enhance Response to Immune Checkpoint Inhibitors
Accumulating Clinical Support that Cabozantinib May Enhance Response to Immune Checkpoint Inhibitors ▪ Cabozantinib potentially creates immune-permissive environment, enhancing activity of ICIs • Immunosuppressive properties of cabo may render tumors more responsive to checkpoint inhibitors ▪ Growin
Slide 11: Growing Body of Evidence Strengthens Development Programs
Growing Body of Evidence Further Strengthens Basis for Ongoing and Near- Term Planned Development Programs for Cabozantinib and ICI Combinations Ongoing Potential Label-enabling Trials Near-Term Planned Phase 3 Trials CheckMate 9ER Ph3: 1L RCC Ph3: DTC Ph3: 1L aHCC Ph3 NSCLC Ph3: 1L RCC Ph1b: Multip
Slide 12: Cabozantinib-related Abstracts Accepted to ASCO 2020
12 Cabozantinib-related Abstracts Accepted to ASCO 2020, Including Readouts and Updates from COSMIC-021 and Collaborative Trials ▪ Cohort 7 (NSCLC) - Abstract 9610 - Cabozantinib in combination with atezolizumab in NSCLC patients previously treated with an immune checkpoint inhibitor: Results from c
Slide 13: Financial Update
Financial Update Chris Senner EVP and CFO 12
Slide 14: Q1'20 Total Revenues
Q1’20 Total Revenues (See press release at www.exelixis.com for full details) $300 COMETRIQ CABOMETYX License Revenues Collaboration Services Revenues 271.7 10.8 $250 240.3 240.3 Q1’20 Notes 8.9 11.9 226.9 215.5 69.1 12.2 10.3 37.7 33.5 ▪ Total revenues of $226.9M $200 20.9 25.6 ▪ $193.9M in net pro
Slide 15: Q1'20 R&D Expenses
Q1’20 R&D Expenses (See press release at www.exelixis.com for full details) $120 97.3 101.9 Q1’20 Notes $100 94.4 5.1 4.3 5.0 5.6 81.9 9.3 ▪ GAAP R&D expenses of $101.9M $80 5.1 20.9 ▪ Non-GAAP** R&D expenses of $96.8M (In Millions) 63.3 14.8 (excl. stock-based compensation expenses, $60 4.3 2.6 bef
Slide 16: Q1'20 SG&A Expenses
Q1’20 SG&A Expenses (See press release at www.exelixis.com for full details) $70 All Other SG&A Expenses Stock-Based Compensation 62.9 60.1 58.8 58.0 Q1’20 Notes $60 8.9 8.2 9.9 51.3 10.2 $50 ▪ GAAP SG&A expenses of $62.9M 8.8 ▪ Non-GAAP SG&A expenses of $54.0M (In Millions) $40 (excl. stock-based c
Slide 17: Q1'20 Net Income
Q1’20 Net Income (See press release at www.exelixis.com for full details) $120 GAAP Net Income Non-GAAP Net Income 107.6 Q1’20 Notes $100 97.5 90.7 85.5 ▪ GAAP net income of $48.6M 79.0 81.0 $80 75.8 68.7 ▪ Non-GAAP net income of $59.4M (In Millions) 59.4 ▪ Non-GAAP net income excludes stock- $60 48
Slide 18: Q1'20 Diluted Earnings Per Share
Q1’20 Diluted Earnings Per Share (EPS) (See press release at www.exelixis.com for full details) $0.40 GAAP diluted EPS Non-GAAP diluted EPS $0.35 0.34 Q1’20 Notes 0.31 0.29 $0.30 ▪ GAAP diluted EPS of $0.15 0.27 0.26 0.25 $0.25 0.24 ▪ Non-GAAP diluted EPS of $0.19 0.22 (In Dollars) $0.20 0.19 ▪ Non-
Slide 19: Fiscal Year 2020 Financial Guidance
Fiscal Year 2020 Financial Guidance* Guidance Total Revenues $850M - $900M Net Product Revenues $725M - $775M Cost of Goods Sold 4% - 5% of net product revenues $460M - $500M R&D Expenses Includes $25M in non-cash stock-based compensation $230M - $250M SG&A Expenses Includes $30M in non-cash stock-b
Slide 20: Commercial Update
Commercial Update PJ Haley EVP, Commercial 19
Slide 21: CABOMETYX Commercial Performance
CABOMETYX Commercial Performance ▪ ICI combinations at ~75% share ▪ CABOMETYX 1L single agent new patient Q1’20 Highlights 1L RCC share (NPS) stable ▪ CheckMate -9ER provides opportunity for ▪ CABOMETYX remains #1 prescribed TKI growth in market share and duration in a growing TKI market ▪ 2L new pa
Slide 22: 2L RCC Market Share Increased in Q1'20
2L RCC Market Share Increased in Q1’20 CABOMETYX 2L RCC (R3M) NEW PATIENT SHARE ▪ Increase in 2L RCC New Patient Share driven by 50% 45% two key dynamics: 45% 40% 38% ▪ More ICI patients progressing from 1L to 2L 35% 31% ▪ CABOMETYX capturing higher market share 30% 27% 26% 24% post-ICI 25% 20% 15%
Slide 23: CABOMETYX Commercial Performance
CABOMETYX Commercial Performance ▪ ICI combinations at ~75% share ▪ CABOMETYX 1L single agent new patient Q1’20 Highlights 1L RCC share (NPS) stable ▪ CheckMate -9ER provides opportunity for ▪ CABOMETYX remains #1 prescribed TKI growth in market share and duration in a growing TKI market ▪ 2L new pa
Slide 24: Q1'20 CABOMETYX Commercial Summary
Q1’20 CABOMETYX Commercial Summary ▪ #1 single-agent TKI prescribed in RCC ▪ Well positioned in currently competitive markets (RCC & HCC) ▪ Long-term growth driven by future indications, including ICI combinations, starting with 1L RCC (CheckMate -9ER), then 1L/2L mCRPC, 1L HCC, 2L DTC, 2L NSCLC 1L
Slide 25: Closing
Closing Michael M. Morrissey, Ph.D. President and CEO 24
Slide 26: Anticipated Key Milestones for 2020
Anticipated Key Milestones for 2020 Program Milestone Timing ✓ Top-line results from Phase 3 trial of cabozantinib + nivolumab in 1L RCC Apr 2020 CheckMate -9ER ❑ File for regulatory approval for cabo + nivo combo in 1L RCC based on positive top-line results 2020 ✓ Present data from mCRPC cohort of
Slide 27: Q&A Session
Q&A Session EXELIX<IS
Slide 28: First Quarter 2020 Financial Results
First Quarter 2020 Financial Results Tuesday, May 5, 2020 Nasdaq: EXEL
Slide 29: Financial Appendix
Financial Appendix 28 EXELIXIS
Slide 30: GAAP Financial Highlights: Q1'20
GAAP Financial Highlights: Q1’20 (in millions, except per share amounts) Q1’19 Q4’19 Q1’20 YoY Delta QoQ Delta Total revenues $215.5 M $240.3 M $226.9 M +5% -6% Cost of goods sold $7.5 M $10.5 M $9.3 M +24% -12% R&D expenses $63.3 M $94.4 M $101.9 M +61% +8% SG&A expenses $60.1 M $58.0 M $62.9 M +5%
Slide 31: Non-GAAP Financial Highlights: Q1'20
Non-GAAP Financial Highlights: Q1’20 (in millions, except per share amounts) Q1’19 Q4’19 Q1’20 YoY Delta QoQ Delta Total revenues $215.5 M $240.3 M $226.9 M +5% -6% Cost of goods sold $7.5 M $10.5 M $9.3 M +24% -12% R&D expenses (a)(b) $59.0 M $88.8 M $96.8 M +64% +9% SG&A expenses (a)(b) $51.9 M $4
Slide 32: Collaboration Revenues Detail
Collaboration Revenues Detail (See press release at www.exelixis.com for full details) $100 Q1’19 – Q1’20 Notes 79.9 $80 ▪ Q1’20 Ipsen royalty to Exelixis of $17.9M 10.2 0.6 ▪ Genentech collaboration: • Q1’20 ex-US COTELLIC royalties $1.3M (In Millions) $60 • Q1’20 US profit share $1.4M 46.6 ▪ Major
Slide 33: Ipsen Royalties
Ipsen Royalties (See press release at www.exelixis.com for full details) $100 Ipsen ex-US and ex-Japan Cabozantinib Franchise Net Product Revenues Ipsen Royalty to Exelixis 81.2 Q1’20 Notes $80 73.3 73.8 ▪ Q1’20 Ipsen ex-US and ex-Japan 66.5 Cabozantinib franchise net product 63.5 revenues of $81.2M
Slide 34: Q1'20 Other Income (Expense), net
Q1’20 Other Income (Expense), net (See press release at www.exelixis.com for full details) $9 $8 7.8 7.7 Q1’20 Notes 7.1 7.2 $7 6.1 ▪ Other income (expense), net in Q1’20 of $6 $7.2M, primarily consists of interest income from growing cash balance (In Millions) $5 ▪ Past five quarters primarily refl
Slide 35: 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 36: GAAP to Non-GAAP Reconciliation (continued)
GAAP to Non-GAAP Reconciliation (continued) (in millions, except per share amounts) Amounts may not sum due to rounding 35
Slide 37: Collaboration Revenues
Collaboration Revenues (in millions) Amounts may not sum due to rounding 36
Slide 38: First Quarter 2020 Financial Results
First Quarter 2020 Financial Results Tuesday, May 5, 2020 Nasdaq: EXEL