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8-K - FOUNDATION MEDICINE, INC. 8-K - Foundation Medicine, Inc. | a51489850.htm |
EX-99.1 - EXHIBIT 99.1 - Foundation Medicine, Inc. | a51489850ex99_1.htm |
Exhibit 99.2
Partner for the Patient Journey J.P. Morgan Healthcare Conference CONFIDENTIAL 1 Investor Presentation
CONFIDENTIAL Forward Looking Statement These slides and 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 twelve months ended December 31, 2015, which is on file with the Securities and Exchange Commission, as well as other risks detailed in 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 and information, 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 or information, including forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
CONFIDENTIAL Cancer Care: Changing the Game vs. Series of stressful, sequential, educated guessesLimited, dynamic information often challenging to incorporate Individual players often don’t collaborate to succeed Comprehensive assessment of a complex opponentStrategic protocols for each moveInformed response to real-time, changing information to improve patient outcomes
CONFIDENTIAL Christine’s Story
CONFIDENTIAL Transforming Cancer Care Foundation Medicine is a molecular information company that is leading a transformation in cancer care.
Molecular Information Solutions Enabling Precision Medicine PHARMA PHYSICIANS Access to therapies through clinical trials Commercialized therapies are available to patients Better patient care Molecular Information Smarter, more efficient R&D FOUNDATIONCORE 100,000+Patient profiles
Track Record of Rapid Innovation and Commercial Execution Advancing the field further, faster CONFIDENTIAL Annual Test Volume 9K 24K 33K 43K 2K 1.1M advanced, metastatic patients per year in the U.S. or ~$3.5B TAM 4M patients globally plus new product expansion or ~$12-15B Global TAM
The CurrentDx Testing Landscape Pharma Co.Dx Co. Pharma Co.Dx Co. Pharma Co.Dx Co. BRACA 1/2ClovisFMI Pharma Co.Dx Co. Chaotic, asymmetricand crowded CONFIDENTIAL Pharma Co.Dx Co. A Physician Guessing Game
Our Vision for aComprehensiveUniversal CDx A Game Changer for Physicians and PharmaFDA approved CGP assay with a comprehensive view of CDx claims PharmaCDx Pharma CDx Pharma CDx Pharma CDx Pharma CDx ClovisBRCA 1/2 CONFIDENTIAL
Parallel Review: One Test, Universal Value Enabling the next major shift in cancer care PHYSICIANS Physician confidenceValidated accuracy Greater patient access to CGPEase of prescribing/billing PHARMA Single-source FDA approved protocolStreamlined, reduced risk regulatory pathway Eliminate economic uncertaintyExpanded reach through FMI’s commercial channel FMI / INVESTORS Lead new FDA oversight paradigmDifferentiated CDx partner Medicare reimbursementCatalyst for private payConsolidate CDx opportunity across pharma
2015 Narrow NSCLC LCD Expanded NSCLC LCDDraft LCDs: Ovarian Melanoma Colorectal 2016 2017 Parallel Review Decision NCD expected to increase private payer momentum Increasing Payer Momentum for CGP Approach Laying the Groundwork for National Coverage Determination CONFIDENTIAL 2014 Private Medicare
Molecular Information Solutions Enabling Precision Medicine Access to therapies through clinical trials Commercialized therapies are available to patients Better patient care Molecular Information Smarter, more efficient R&D FOUNDATIONCORE 100,000+Patient profiles PHARMA PHYSICIANS
Companion Diagnostic Solutions Precision Clinical Trial Solutions Molecular Information Solutions Molecular Information Solutions for Pharma Changing the Game for Drug Developers CONFIDENTIAL Assays Services Data
CONFIDENTIAL A Continuing Story of Growth and Execution $ MILLIONS $10.6 $29.0 $61.1 $93.2 $2.1 $116.9 Annual Revenue Growth
2016 Accomplishments CONFIDENTIAL $116.9M $143M 43,686 Total Revenue, 25% growth year-over-year Cash, cash equivalents and marketable securities Clinical Tests reported, 32% growth year-over-year Launched FoundationACTLaunched FoundationFOCUS™ CDx BRCA, the first-ever FDA approved NGS CDxObtained broadened Medicare LCD and expanded national TPP coverageGrew SmartTrials program and other data solutions with multiple BioPharmasCollaborated with Roche on ex-US expansion and selected Penzberg Germany as first EU lab site
2017 Business Objectives CONFIDENTIAL Advance the Universal Companion Diagnostic assay through the FDA and CMS parallel review process to decision and launch during the second half of 2017.Broaden Medicare and third party payer coverage for the company’s CGP products.Grow clinical volume across the entire product portfolio, including expanded global market presence.Expand the Biopharma business, including additional companion diagnostic collaborations and SmartTrials clinical trial access programs.
Partner for the Patient Journey J.P. Morgan Healthcare Conference CONFIDENTIAL 17 Investor Presentation