Foundation Medicine — Merger or Acquisition (January 2015)
49 slides from Foundation Medicine's merger presentation, Jan 14, 2015
Slide 1: Foundation Medicine: The Molecular Information Company
Foundation Medicine The Molecular Information Company
Slide 2: Forward Looking Statements
FORWARD LOOKING STATEMENTS These slides and the accompanying oral presentation contain forward-looking statements and information. These materials, including any accompanying oral presentation, contain forward-looking statements about our business. You should not place undue reliance on forward- loo
Slide 3: Who We Are
WHO WE ARE Foundation Medicine is a molecular information company that’s leading a transformation in cancer care.
Slide 4: Slide 4
Slide 5: Paradigm Shift
PARADIGM SHIFT
Slide 6: Cancer is a disease of the genome
Cancer is a disease of the genome ©2015 Foundation Medicine, Inc. 6
Slide 7: Clinical Oncology, Genome Technology, Cancer Biology, Information Science
CLINICAL ONCOLOGY GENOME TECHNOLOGY CANCER BIOLOGY INFORMATION SCIENCE
Slide 8: Foundation Medicine
FOUNDATION MEDICINE®
Slide 9: Comprehensive Molecular Tests, Knowledgebase, Broad Relationships
COMPREHENSIVE MOLECULAR TESTS RAPIDLY EXPANDING KNOWLEDGEBASE BROAD RELATIONSHIPS
Slide 10: Physicians, Patients, Pharma, Payors, Regulators
PHYSICIANS PATIENTS PHARMA PAYORS REGULATORS
Slide 11: Category One: Single-Marker Molecular Test
CATEGORY ONE Routine Single-Marker Molecular Test Routine single marker molecular tests such as IHC, PCR and FISH that have been used for decades and will continue to play an important role in cancer diagnosis missed missed found missed missed CATEGORY TWO CATEGORY THREE
Slide 12: Multi-gene Hot Spot Test
CATEGORY ONE Multi-gene “Hot Spot” Test The hot spot NGS panels identify pre-specified mutations occurring in very limited areas of genes of interest and fail to detect all classes of genomic alterations missed found found missed missed CATEGORY TWO CATEGORY THREE
Slide 13: Comprehensive Genomic Profiling Approach
CATEGORY ONE CATEGORY TWO FMI’s comprehensive genomic profiling approach of testing all of the known clinically relevant cancer genes for all classes of alterations found found found found found CATEGORY THREE
Slide 14: Sensitivity, Specificity and Turnaround Time
99% SENSITIVITY 99% SPECIFICITY 99% SENSITIVITY 95% SPECIFICITY 11-14 DAYS TURNAROUND TIME 15-18 DAYS TURNAROUND TIME
Slide 15: Slide 15
Slide 16: Single Marker, Hot Spot, FoundationOne
CATEGORY ONE SINGLE MARKER CATEGORY TWO HOT SPOT CATEGORY THREE FOUNDATIONONE
Slide 17: Single Marker, Hot Spot, FoundationOne
CATEGORY ONE SINGLE MARKER CATEGORY TWO HOT SPOT CATEGORY THREE FOUNDATIONONE
Slide 18: Single Gene, Hot Spot, FoundationOne
CATEGORY ONE SINGLE GENE CATEGORY TWO HOT SPOT CATEGORY THREE FOUNDATIONONE
Slide 19: Payors, Regulators, Guidelines
PAYORS REGULATORS GUIDELINES CATEGORY ONE SINGLE GENE CATEGORY TWO HOT SPOT CATEGORY THREE FOUNDATIONONE
Slide 20: Priority Health coverage decision for FoundationOne and FoundationOne Heme
Broad coverage decision by Priority Health for both FoundationOne and FoundationOne Heme is initial, tangible progress with payors Continued progress with the relevant MACs and key private payors PAYORS REGULATORS GUIDELINES
Slide 21: Regulators: LDT regulations and QSR-compliant lab
PAYORS REGULATORS GUIDELINES Recently-proposed LDT regulations likely to be yet another differentiator for FMI FMI’s QSR-compliant lab, which will support the development and processing of FDA approved tests, is expected to be complete in 2015 Recent FOCR white paper with FDA contribution appears to
Slide 22: NCCN guidelines endorse comprehensive genomic profiling
Recently updated NCCN guidelines for NSCLC “strongly endorse” a comprehensive genomic profiling approach, and clinical trials are highlighted as part of the rationale for testing PAYORS REGULATORS GUIDELINES
Slide 23: Commercial Leader
COMMERCIAL LEADER
Slide 24: Rapid Awareness
RAPID AWARENESS 2009 2010 ~35K tests reported to physicians since launch Majority of oncologists not aware of NGS testing FMI founded Theme of next-gen sequencing becoming relevant for clinical use at ASCO FMI launches FoundationOne at ASCO FMI launches FoundationOne Heme at ASH
Slide 25: Commercial Adoption
COMMERICAL ADOPTION Rapid growth in number of tests reported to physicians… 7,233 6,428 5,908 4,702 3,752 2,577 1,626 1,140 244 492 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 2012 2013 2014
Slide 26: Financial Performance
FINANCIAL PERFORMANCE … resulting in strong revenue growth $2M $11M $29M $61M
Slide 27: Perform: Test, Deliver, Info
PERFORM TEST DELIVER INFO
Slide 28: Perform: Test, Deliver, Info
PERFORM TEST DELIVER INFO
Slide 29: ~35,000 Patients
~35,000 PATIENTS Majority of tests delivered to community oncologists in recent quarters
Slide 30: Clinically relevant treatment options identified
18% no identified targeted treatment option 31% through alternative testing methods CLINICALLY RELEVANT TREATMENT OPTIONS 82% through FoundationOne and FoundationOne Heme testing
Slide 31: Breakthrough and Breadth
BREAKTHROUGH BREADTH 1 Stage IV non-small cell lung cancer 2 Rare or uncommon tumors 3 Exhausted guideline-driven testing and therapies 4 Highly-aggressive, treatment resistant tumors 5 Cancer of unknown primary 6 Limited tissue availability ©2015 Foundation Medicine, Inc. 31
Slide 32: A High Unmet Need
A HIGH UNMET NEED Initial focus (unmet need population) ~1 million patients FoundationOne Heme focus ~1.1 million patients Potential expansion as use expands ~2 million patients US annual cancer prevalence ~13 million patients
Slide 33: Patient Diagnosis Results Treatment
PATIENT DIAGNOSIS RESULTS TREATMENT ©2015 Foundation Medicine, Inc. 33
Slide 34: Patient X
“PATIENT X” 60 year-old woman presented with hematuria.
Slide 35: Diagnosis
DIAGNOSIS Cystoscopy revealed a bladder mass, and biopsy confirmed muscle-invasive urothelial carcinoma. Further testing indicated stage III disease and the patient received preoperative chemotherapy followed by radical cystectomy and adjuvant chemotherapy. Two months after adjuvant therapy, the pat
Slide 36: Results
RESULTS Primary tumor tissue sent to FMI for testing. Alteration in NF2 gene was detected.
Slide 37: Patient Results
PATIENT RESULTS ©2015 Foundation Medicine, Inc. 37
Slide 38: Treatment
TREATMENT Everolimus plus paclitaxel given mimicking regimen in ongoing phase II. Patient experienced durable partial response for over one year and ongoing.
Slide 39: Before and After
BEFORE AFTER
Slide 40: Decision Support Tools and Biopharma Relationships
DECISION SUPPORT TOOLS FOUNDATIONONE CARELINE / EMERGINGMED CULTIVATE BIOPHARMA RELATIONSHIPS PARTNER WITH LEADING DATA COMPANIES DELIVER TECHNOLOGY PRODUCTS
Slide 41: FoundationICE
FOUNDATIONICE ©2015 Foundation Medicine, Inc. 41
Slide 42: PatientMatch
PATIENTMATCH ©2015 Foundation Medicine, Inc.
Slide 43: PatentMatch
PATENTMATCH ©2015 Foundation Medicine, Inc.
Slide 44: PatentMatch
PATENTMATCH ©2015 Foundation Medicine, Inc.
Slide 45: Product Pipeline
PRODUCT PIPELINE Liquid Biopsy products Enhancements of existing tests Technology products Immuno-oncology products Regulated products Future innovations
Slide 46: The Go-To Resource
THE GO-TO RESOURCE
Slide 47: 2014 Accomplishments
ACCOMPLISHMENTS 1 Continued rapid growth and commercial/financial execution, with clinical volumes growing 167% to 24,271* and revenue growing 111% to $61.1* million in 2014 2 biopharmaceutical Continued expansion partnerships of biopharma on relationships, >100 clinical trials with in >20 2014 3 Re
Slide 48: Transforming Oncology: Strategic Collaboration with Roche
TRANSFORMING ONCOLOGY FMI’S STRATEGIC COLLABORATION WITH ROCHE Focuses on improving patient care in oncology The strategic collaboration aims to further advance FMI’s leading molecular information platform while providing Roche with the opportunity to identify and develop novel treatment options for
Slide 49: Important Information and Where to Find It
FOUNDATION MEDICINE® Important Information and Where to Find It The tender offer described in this document (the “Offer”) has not yet commenced, and this document is neither an offer to purchase nor a solicitation of an offer to sell any shares of the common stock of Foundation Medicine or any other
Foundation Medicine — Merger or Acquisition (January 2015) on 6ix