Exelixis - Q2 14 Earnings Call Presentation

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  • 1. EXELIXIS, INC (NASDAQ: EXEL) Q2 2014 Financial Results July 31, 2014
  • 2. Today’s Agenda Introduction Susan Hubbard, Investor Relations Overview Mike Morrissey, President and CEO Commercial Updates Scott Garland, EVP and CCO Financial Updates Deborah Burke, VP and Interim CFO Development Update Gisela Schwab, EVP and CMO Q&A All 2 Press release and webcast (live and archived) available at www.exelixis.com
  • 3. 3 Forward-Looking Statements This presentation, including any oral presentation accompanying it, contains forward-looking statements, including, without limitation, statements related to: the continued development and clinical, therapeutic and commercial potential of, and opportunities for, cabozantinib and cobimetinib; anticipated developments in, and the expected timing of events with respect to, various cabozantinib trials, including the availability of top-line results from phase 3 pivotal trials; Exelixis’ strategy for advancing the cabozantinib development program; the designs, plans and goals for ongoing and planned clinical trials of cabozantinib; the commercialization of COMETRIQ® (cabozantinib) in the approved medullary thyroid cancer indication and in new indications if approved for use in such indications; Exelixis’ expectations for revenue growth and future product sales; future data presentations; future regulatory filings and potential approvals; the potential commercialization of cobimetinib and Exelixis’ anticipated co- promotion efforts with Roche/Genentech; Exelixis' financial guidance and outlook; Exelixis’ top priorities for 2014; and Exelixis’ goals to bring new therapies to patients with cancer and build value for shareholders. These statements are based on Exelixis’ current expectations, assumptions, estimates and projections about its business and its industry and involve known and unknown risks, uncertainties and other factors that may cause Exelixis’ or its industry’s results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied in, or contemplated by, the forward-looking statements. Words such as “continue,” “expect,” “will,” “may,” “can,” “focus,” “progress,” “look forward,” “believe,” “potential,” “possibility,” “outlook,” “guidance,” “remain,” “anticipate,” “new,” “opportunity,” “priorities,” “strategy,” “support,” “enable,” “evaluate,” “promising,” “encouraged,” “on track,” “ongoing,” “plan,” “objectives,” “goals,” “further,” “beyond,” “initiate,” “working towards,” or the negative of such terms or other similar expressions, identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements. Exelixis’ actual results and the timing of events may differ significantly from the results discussed in the forward-looking statements. Factors that might cause such a difference include, without limitation: risks related to the potential failure of cobimetinib or cabozantinib to demonstrate safety and efficacy in clinical testing; the availability of data at the expected times; the clinical, therapeutic and commercial value of cobimetinib and cabozantinib; the uncertain timing and level of expenses associated with the development of cabozantinib; Exelixis' ability to conduct clinical trials of cabozantinib sufficient to achieve a positive completion; Exelixis' dependence on its relationship with Roche/Genentech for the development of cobimetinib and Exelixis’ ability to maintain its rights under the collaboration; the risk that unanticipated developments could adversely affect the commercialization of COMETRIQ; the degree of market acceptance of COMETRIQ and the availability of coverage and reimbursement for COMETRIQ; risks and uncertainties related to regulatory approval processes and compliance with applicable regulatory requirements, including healthcare fraud and abuse laws and post-marketing requirements; Exelixis' dependence on third-party vendors; the sufficiency of Exelixis' capital and other resources; market competition; changes in economic and business conditions; and other factors discussed under the caption “Risk Factors” of Exelixis’ quarterly report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on July 31, 2014 and in Exelixis' other filings with the SEC. The forward-looking statements made in this presentation, including any oral presentation accompanying it, speak only as of the date on which the statements are made. Exelixis expressly disclaims any duty, obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Exelixis' expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
  • 4. Overview Michael Morrissey, President & CEO
  • 5. Key Highlights Planning for key cabozantinib milestones expected in 2H 2014 • Top-line results for COMET-1 and COMET-2 • Overall survival (OS) analysis from EXAM trial • Complete enrollment for METEOR trial in 2L renal cell cancer (RCC) in anticipation of top-line results in 2015 Solid QoQ revenue growth for COMETRIQ® from Q1’14 to Q2’14 Anticipating Roche’s presentation of coBRIM data at ESMO • Follows positive top-line results announced earlier this month 5
  • 6. Commercial Update Scott Garland, EVP and CCO
  • 7. COMETRIQ® Q2 2014 Sales Total net COMETRIQ revenues of $6.6M in Q2 2014 • Aggregate 34% increase vs. Q1’14 • Net sales of $6.1M in the U.S., 27% increase vs. Q1’14 Q2 Average treatment duration ~8 months for active MTC patients • 1/3 of active patients on drug for one year or longer • 90% of prescribing oncologists with favorable impression of drug; 80% found drug more favorable than other tyrosine kinase inhibitors Solid increase in number of new MTC patients treated in Q2 • As measured by new MTC cartons shipped • Growth partially driven by increasing sales and marketing traction • 15-person sales team made nearly 2,000 customer calls in Q2 7
  • 8. Additional Commercial Updates Continued progress from Sobi on European commercialization • In the U.K., obtained reimbursement coverage via Cancer Drugs Fund and initiated commercialization activities • Negotiating pricing and reimbursement in other countries • A lengthy process; expect slower ramp-up than in U.S. Preparing for potential co-promotion of cobimetinib with Genentech • More specifics as appropriate, and as data become available 8
  • 9. Financial Update Deborah Burke, VP and Interim CFO
  • 10. Q2 2014 Financial Results (See press release at www.exelixis.com for full details) Net Revenue: $6.6M, all from COMETRIQ sales • Increase of $2.5M in product revenue vs. Q2’13 reflects ramp-up in sales following launch • Decrease of $7.8M in contract and license revenue vs. Q2’13 from collaboration revenue fully recognized in 2013 R&D Expenses: $51.0M, compared to $49.1M in Q2’13 • Increase of $1.9M year over year to support on-going activities in five phase 3 pivotal trials SG&A Expenses: $16.5M, compared to $13.2M in Q2’13 • Increase of $3.3M primarily due to higher personnel expenses related to expansion of U.S. sales force 10
  • 11. Q2 2014 Financial Results (continued) (See press release at www.exelixis.com for full details) Total Operating Expenses: $68.3M, compared to $63.2M in Q2’13 • Increase of $5.1M due to R&D and SG&A expenses Other Expense: ($11.7M), compared to ($10.9M) in Q2’13 • $7.3M in 2014 of non-cash interest expense related to both 4.25% Convertible Senior Subordinated Notes due 2019 and financing arrangement with Deerfield Quarter-End Cash: $352.0M* • Compared to $415.9M at year-end 2013 Maintaining financial guidance for full-year 2014 • Total costs and expenses: $250-280M • Year-end cash >$200M* 11 * Includes cash and cash equivalents, short- and long-term investments and short- and long-term restricted cash and investments
  • 12. Development Update Gisela Schwab, EVP and CMO
  • 13. 13 Broad Cabozantinib Development Program Phase 3 Pivotal Trials • COMET-1 (CRPC; OS) • COMET-2 (CRPC; Pain Palliation) • METEOR (RCC) • CELESTIAL (HCC) • EXAM (MTC) EXELIXIS RESOURCES Phase 1 and 2 Clinical Trials • National Cancer Institute’s Cancer Therapy Evaluation Program (NCI-CTEP) • Investigator-Sponsored Trial (IST) Program COLLABORATIONS
  • 14. Earlier-stage CRPC: phase 2 combination trial with abiraterone well underway Hepatocellular cancer: CELESTIAL pivotal trial enrolling • Vs. placebo in patients previously treated with sorafenib (n=760) • OS endpoint • Top-line data expected 2016/17 Metastatic renal cell cancer: METEOR on track for data in 2015 • Vs. everolimus in patients who have received and progressed on/after at least one prior VEGFR TKI (n=650) • Progression-Free Survival (PFS) endpoint, OS secondary endpoint • Expect to complete enrollment in 2014 and anticipate top-line results in 2015 Other Ongoing Studies with Cabozantinib 14 Note: Cabozantinib is not approved for use under investigation in these trials.
  • 15. More than 50 ongoing or planned Exelixis-sponsored trials, IST and CTEP studies Objectives for IST and CTEP programs • Signal detection • Evaluation of combination potential • Randomized evaluation of activity observed in earlier trials Two randomized phase 2 ISTs have reached full enrollment • Eastern Cooperative Oncology Group (ECOG) trial in 2nd or 3rd line EGFR wild type NSCLC: cabozantinib vs. erlotinib vs. cabozantinib + erlotinib • Gynecologic Oncology Group (GOG) trial in platinum resistant/refractory ovarian cancer patients: cabozantinib vs.weekly paclitaxel • Both studies expecting data late 2014/early 2015 Investigator-Sponsored and NCI-CTEP Cabozantinib Trials 15 Note: Cabozantinib is not approved for use under investigation in these trials.
  • 16. Cobimetinib: Positive Top-Line Results from coBRIM Statistically significant increase in PFS for cobimetinib+vemurafenib vs. vemurafenib alone in advanced melanoma • Unresectable locally advanced or metastatic melanoma harboring the BRAF V600 mutation • Adverse events consistent with prior study Roche plans to present data at ESMO (Madrid, Sept. 26-30, 2014) and initiate regulatory filings before year-end Genentech also evaluating cobimetinib in other combinations • With anti-HER3/EGFR antibody in KRAS-mutated advanced solid tumors including colorectal and non-small cell lung cancers (Ph 1b) • With anti-PDL1 antibody in locally advanced or metastatic tumors (Ph 1b) • Other studies 16
  • 17. Closing Michael Morrissey, President and CEO
  • 18. Top Priorities for Exelixis in 2014 Top-line data readouts from the COMET studies Working towards submitting regulatory filings, assuming positive COMET data Completing enrollment in METEOR, phase 3 pivotal trial in metastatic renal cell carcinoma, in anticipation of top line results in 2015 Planning commercial build-out supporting the prostate cancer indication in the US and EU, pending positive COMET data 18 1 2 3 4
  • 19. Question & Answer Session
  • 20. EXELIXIS, INC (NASDAQ: EXEL) Q2 2014 Financial Results July 31, 2014