UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
SCHEDULE 14A
Proxy Statement Pursuant to Section 14(a) of the
Securities Exchange Act of 1934
(Amendment No. )
Filed by the Registrant x Filed by a Party other than the Registrant ¨
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| ¨ | Preliminary Proxy Statement | |
| ¨ | Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) | |
| ¨ | Definitive Proxy Statement | |
| ¨ | Definitive Additional Materials | |
| x | Soliciting Material Pursuant to §240.14a-12 | |
FOUNDATION MEDICINE, INC.
(Name of Registrant as Specified In Its Charter)
N/A
(Name of Person(s) Filing Proxy Statement, if other than the Registrant)
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Filed by Foundation Medicine, Inc.
Pursuant to Rule 14a-12 under the Securities Exchange Act of 1934
Subject Company: Foundation Medicine, Inc.
Commission File No.: 001-36086
Set forth below is a copy of the slide deck used by Dr. Michael Pellini, Foundation Medicine, Inc. CEO, at a presentation at the J.P. Morgan Healthcare Conference on January 14, 2015.
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Foundation Medicine
The Molecular Information Company
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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- looking statements as these statements are based upon our current expectations, forecasts and assumptions and are subject to significant risks and uncertainties. These statements may be identified by words such as “may,” “will,” “should,” “could,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “forecast,” “continue” or the negative of these terms or other words or terms of similar meaning. Risks and uncertainties that could cause our actual results to differ materially from those set forth in any forward-looking statements include, but are not limited to, the matters listed under “Risk Factors” in our Annual Report on Form 10- K for the year ended December 31, 2013 and our subsequent filings with the Securities and Exchange Commission. These reports are available at www.sec.gov or by contacting our investor relations department at ir@foundationmedicine.com.
Statements, including forward-looking statements, speak only to the date they are provided (unless an earlier date is indicated), and we do not undertake any obligation to publicly update any statements, including forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
Important Information Related to the Tender Offer 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 common stock of Foundation Medicine or any other securities. On the commencement date of the Offer, a tender offer statement on Schedule TO, including an offer to purchase, a letter of transmittal and related documents, will be filed with the United States Securities and Exchange Commission (the “SEC”) by Roche, and a Solicitation/Recommendation Statement on Schedule 14D-9 will be filed with the SEC by Foundation Medicine. The offer to purchase shares of Foundation Medicine common stock will only be made pursuant to the offer to purchase, the letter of transmittal and related documents filed as a part of the Schedule TO. Also in connection with the proposed transactions, Foundation Medicine will file a proxy statement with the SEC. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE TENDER OFFER STATEMENT, THE SOLICITATION/RECOMMENDATION STATEMENT REGARDING THE OFFER AND THE PROXY STATEMENT, AS THEY MAY BE AMENDED FROM TIME TO TIME, WHEN
THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION. Investors and security holders may obtain a free copy of these materials (when available) and other documents filed with the SEC at the website maintained by the SEC at www.sec.gov or by directing such requests to the Information Agent for the tender offer which will be named in the tender offer statement. Copies of Foundation Medicine’s filings with the SEC may be obtained free of charge at the “Investors & Press” section of Foundation Medicine’s website at www.foundationmedicine.com.
Foundation Medicine and its directors, executive officers and other members of its management and employees may be deemed under SEC rules to be participants in the solicitation of proxies of Foundation Medicine’s stockholders in connection with the proposed transactions. Information concerning the interests of Foundation Medicine’s participants in the solicitation, which may, in some cases, be different than those of Foundation Medicine’s stockholders generally, is set forth in the materials filed by Foundation Medicine with the SEC, including in Foundation Medicine’s definitive proxy statement filed with the SEC on April 30, 2014, and will be set forth in the proxy statement relating to the transactions when they become available. These documents can be obtained free of charge from the sources indicated above.
©2015 Foundation Medicine, Inc. 2
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WHO WE ARE
Foundation Medicine is a molecular information company that’s leading a transformation in cancer care.
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©2015 Foundation Medicine, Inc. 4
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PARADIGM
SHIFT
©2015 Foundation Medicine, Inc. 5
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Cancer is a disease of the genome
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CLINICAL ONCOLOGY
GENOME TECHNOLOGY
CANCER BIOLOGY
INFORMATION SCIENCE
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FOUNDATION
MEDICINE®
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COMPREHENSIVE MOLECULAR TESTS
RAPIDLY EXPANDING KNOWLEDGEBASE
BROAD RELATIONSHIPS
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PHYSICIANS
PATIENTS
PHARMA
PAYORS
REGULATORS
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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
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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
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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
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99%
SENSITIVITY
99%
SPECIFICITY
99%
SENSITIVITY
95%
SPECIFICITY
11-14 DAYS
TURNAROUND TIME
15-18 DAYS
TURNAROUND TIME
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CATEGORY ONE
SINGLE MARKER
CATEGORY TWO
HOT SPOT
CATEGORY THREE
FOUNDATIONONE
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CATEGORY ONE
SINGLE MARKER
CATEGORY TWO
HOT SPOT
CATEGORY THREE
FOUNDATIONONE
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CATEGORY ONE
SINGLE GENE
CATEGORY TWO
HOT SPOT
CATEGORY THREE
FOUNDATIONONE
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PAYORS
REGULATORS
GUIDELINES
CATEGORY ONE
SINGLE GENE
CATEGORY TWO
HOT SPOT
CATEGORY THREE
FOUNDATIONONE
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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
©2015 Foundation Medicine, Inc. 20
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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 be in-line with our comprehensive approach
©2015 Foundation Medicine, Inc. 21
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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
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COMMERCIAL
LEADER
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RAPID
AWARENESS
2014
2013
2012
2011
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
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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
878
1,140
244 492
Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
2012 2013 2014
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FINANCIAL
PERFORMANCE
… resulting in strong revenue growth
$2M
$11M
$29M
$61M
2011
2012
2013
2014
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PERFORM
TEST
DELIVER
INFO
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PERFORM
TEST
DELIVER
INFO
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~35,000 PATIENTS
Majority of tests delivered to community oncologists in recent quarters
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18% no identified targeted treatment option
31% through alternative testing methods
CLINICALLY RELEVANT
TREATMENT OPTIONS
82% through FoundationOne and FoundationOne Heme testing
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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
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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
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PATIENT DIAGNOSIS RESULTS TREATMENT
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“PATIENT X”
60 year-old woman presented with hematuria.
©2015 Foundation Medicine, Inc. 34
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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 patient relapsed and continued to progress after two months of docetaxel monotherapy, a standard of care after failure of platinum-based treatment.
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RESULTS
Primary tumor tissue sent to FMI for testing. Alteration in NF2 gene was detected.
©2015 Foundation Medicine, Inc. 36
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PATIENT RESULTS
©2015 Foundation Medicine, Inc. 37
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TREATMENT
Everolimus plus paclitaxel given mimicking regimen in ongoing phase II. Patient experienced durable partial response for over one year and ongoing.
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BEFORE
AFTER
©2015 Foundation Medicine, Inc. 39
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DECISION
SUPPORT TOOLS
FOUNDATIONONE CARELINE / EMERGINGMED
CULTIVATE
BIOPHARMA RELATIONSHIPS
PARTNER
WITH LEADING DATA COMPANIES
DELIVER
TECHNOLOGY PRODUCTS
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FOUNDATIONICE
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PATIENTMATCH
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PATENTMATCH
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PATENTMATCH
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PRODUCT
PIPELINE
Liquid Biopsy products
Enhancements of existing tests
Technology products
Immuno-oncology products
Regulated products
Future innovations
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THE GO-TO
RESOURCE
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2014
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 Received full approval from the New York State Department of Health of FoundationOne and FoundationOne Heme
4 FoundationOne Secured broad reimbursement Heme from Priority coverage Health for FoundationOne and
5 Launched enhanced version of FoundationOne
6 partnership Launched FoundationOne in October to CareLine improve actionability and announced of FMI EmergingMed tests
7 launched Announced ICE two 2 physician data relationships portal with COTA and Flatiron and
8 abstracts 38 peer-reviewed publications and 94 podium presentations and
* Unaudited
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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 patients
Enhances molecular information business and R&D capabilities
5-year commitment to broad utilization of FMI molecular information platform for Roche pipeline assets
New product development collaborations: ctDNA, cancer immunotherapy, companion diagnostics
Expands commercialization efforts
Enhanced market development efforts in U.S. through Genentech resources
Acceleration of global access through Roche’s ex-U.S. commercial infrastructure
Results in Roche acquiring majority interest in FMI
Roche to acquire majority interest in FMI up to 56.3% on a fully diluted basis through a tender (aggregate value of ~$780 million) and acquisition of newly issued shares
Strengthens FMI’s balance sheet and supports investment opportunities
Includes primary capital investment of $250 million in FMI at $50 per share
>$150 million in additional payments and milestones over 5 years from R&D collaboration
Additional cash and in-kind support from commercialization activities
Maintains independent innovation
FMI retains operating independence and current management team while leveraging Roche’s expertise and breadth of experience in precision medicine and oncology
©2015 Foundation Medicine, Inc. 48
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FOUNDATION
MEDICINE®
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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 securities. On the commencement date of the Offer, a tender offer statement on Schedule TO, including an offer to purchase, a letter of transmittal and related documents, will be filed with the United States Securities and Exchange Commission (the “SEC”) by Roche Holdings, Inc., and a Solicitation/Recommendation Statement on Schedule 14D-9 will be filed with the SEC by Foundation Medicine. The offer to purchase shares of Foundation Medicine common stock will only be made pursuant to the offer to purchase, the letter of transmittal and related documents filed as a part of the Schedule TO. Also in connection with the proposed transactions, Foundation Medicine will file a proxy statement with the SEC. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE TENDER OFFER STATEMENT, THE SOLICITATION/RECOMMENDATION STATEMENT REGARDING THE OFFER AND THE PROXY STATEMENT, AS THEY MAY BE AMENDED FROM TIME TO TIME, WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION. Investors and security holders may obtain a free copy of these statements (when available) and other documents filed with the SEC at the website maintained by the SEC at www.sec.gov or by directing such requests to the Information Agent for the tender offer which will be named in the tender offer statement. Copies of Foundation Medicine’s filings with the SEC may be obtained free of charge at the “Investors & Press” section of Foundation Medicine’s website at www.foundationmedicine.com or by contacting investor relations at 617-418-2283.
Certain Information Regarding Participants
Foundation Medicine and its directors, executive officers and other members of its management and employees may be deemed under SEC rules to be participants in the solicitation of proxies of Foundation Medicine’s stockholders in connection with the proposed transactions. Information concerning the interests of Foundation Medicine’s participants in the solicitation, which may, in some cases, be different than those of Foundation Medicine’s stockholders generally, is set forth in materials filed by Foundation Medicine with the SEC, including in Foundation Medicine’s definitive proxy statement filed with the SEC on April 30, 2014, and will be set forth in the proxy statement relating to the transactions when they become available. These documents can be obtained free of charge from the sources indicated above.