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`10-K 1 fmi-10k_20171231.htm 10-K
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` UNITED STATES
`SECURITIES AND EXCHANGE COMMISSION
`Washington, D.C. 20549
`Form 10-K
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`(Mark One)
`☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
`For the fiscal year ended December 31, 2017
`or
`☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
`For the transition period from to
`Commission File Number 001-36086
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`FOUNDATION MEDICINE, INC.
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`(Exact name of registrant as specified in its charter)
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`Delaware
`(State or other jurisdiction of
`incorporation or organization)
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`27-1316416
`(IRS Employer
`Identification No.)
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`150 Second Street
`Cambridge MA, 02141
`(Address of principal executive offices, including zip code)
`Registrant’s Telephone Number, Including Area Code:
`(617) 418-2200
`Securities registered pursuant to Section 12(b) of the Act:
`Common Stock, $0.0001 Par Value
`
`The NASDAQ Global Select Market
`(Title of each class)
`(Name of each exchange on which registered)
`
`Securities registered pursuant to Section 12(g) of the Act: NONE
`Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☒ No ☐
`Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐ No ☒
`Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of
`1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such
`filing requirements for the past 90 days. Yes ☒ No ☐
`Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File
`required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter
`period that the registrant was required to submit and post such files). ☒ Yes ☐ No
`Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained,
`to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any
`amendment to this Form 10-K. ☒
`Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, an emerging growth company,
`or a smaller reporting company. See definitions of “large accelerated filer,” “accelerated filer,” “emerging growth company,” and “smaller reporting
`company” in 12b-2 of the Exchange Act.
`☒
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`Accelerated filer
` Large accelerated filer
`☐
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`Smaller reporting company
`Non-accelerated filer
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`Emerging growth company
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`If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with
`any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒
`Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
`As of June 30, 2017, the last business day of the registrant’s most recently completed second fiscal quarter, the aggregate market value of common
`stock held by non-affiliates of the registrant computed by reference to the last reported sale price of the registrant’s common stock on the Nasdaq Global
`Select Market as of such date was approximately $573.7 million. As of March 2, 2018, there were 36,881,792 shares of the registrant’s common stock,
`$0.0001 par value per share, outstanding.
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`DOCUMENTS INCORPORATED BY REFERENCE
`The registrant intends to file a definitive proxy statement pursuant to Regulation 14A within 120 days of the end of the fiscal year ended
`December 31, 2017. Portions of such definitive proxy statement are incorporated by reference into Part III of this Annual Report on Form 10-K.
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`Case 1:20-cv-01580-LPS Document 9-2 Filed 12/10/20 Page 4 of 149 PageID #: 709
`FOUNDATION MEDICINE, INC.
`ANNUAL REPORT ON FORM 10-K
`For the Year Ended December 31, 2017
`
`
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`PART I
`Item 1. Business
`Item 1A. Risk Factors
`Item 1B. Unresolved Staff Comments
`Item 2. Properties
`Item 3. Legal Proceedings
`Item 4. Mine Safety Disclosures
`PART II
`Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
`Item 6. Selected Financial Data
`Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations
`Item 7A. Quantitative and Qualitative Disclosures About Market Risk
`Item 8. Financial Statements and Supplementary Data
`Item 9. Controls and Procedures
`Item 9A. Other Information
`PART III
`Item 10. Directors, Executive Officers and Corporate Governance
`Item 11. Executive Compensation
`Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
`Item 13. Certain Relationships and Related Transactions, and Director Independence
`Item 14. Principal Accounting Fees and Services
`PART IV
`Item 15. Exhibits, Financial Statement Schedules
`Item 16. Form 10-K Summary
`SIGNATURES
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`PART I
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`This Annual Report on Form 10-K, or this Annual Report, contains forward-looking statements within the meaning of Section 27A of
`the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and is subject to the “safe
`harbor” created by those sections. Any statements about our expectations, beliefs, plans, objectives, assumptions or future events or
`performance are not historical facts and may be forward-looking. Some of the forward-looking statements can be identified by the use of
`forward-looking terms such as “believes,” “expects,” “may,” “will,” “should,” “seek,” “intends,” “plans,” “estimates,” “projects,”
`“anticipates,” or other comparable terms. These forward-looking statements involve risk and uncertainties. We cannot guarantee future
`results, levels of activity, performance, or achievements, and you should not place undue reliance on our forward-looking statements. Our
`actual results may differ significantly from the results discussed in the forward-looking statements. Factors that might cause such a
`difference include, but are not limited to, those set forth in “Item 1A. Risk Factors” and elsewhere in this Annual Report. Except as may be
`required by law, we have no plans to update our forward-looking statements to reflect events or circumstances after the date of this Annual
`Report. We caution readers not to place undue reliance upon any such forward-looking statements, which speak only as of the date made.
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`Unless the content requires otherwise, references to “Foundation Medicine,” “the Company,” “we,” “our,” and “us,” in this Annual
`Report refer to Foundation Medicine, Inc. and its subsidiaries.
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`ITEM 1.
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`BUSINESS
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`Overview
`We are a molecular information company focused on fundamentally changing the way in which patients with cancer are evaluated
`and treated. We believe an information-based approach to making clinical treatment decisions based on comprehensive genomic profiling,
`or CGP, will become standard of care for patients with cancer. We derive revenue from selling services that are enabled by our molecular
`information platform to physicians and biopharmaceutical companies. Our platform includes proprietary methods and algorithms for
`analyzing specimens across all types of cancer, and for incorporating that information into clinical care in a concise and user-friendly
`fashion. Our services provide genomic insights about each patient’s individual cancer obtained from that analysis, enabling physicians to
`optimize treatments in clinical practice and biopharmaceutical companies to develop targeted therapies and immunotherapies more
`effectively. We believe we have a significant first-mover advantage in providing high-quality, CGP and molecular information services
`globally on a commercial scale.
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`We offer a full suite of validated clinical assays based on our CGP approach:
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`FoundationOne® for solid tumors, our flagship assay, that we commercialized in 2012;
`FoundationOne®Heme for blood-based cancers, or hematologic malignancies, including leukemia, lymphoma, and
`advanced sarcomas, that we commercialized in 2013;
`FoundationACT® (Assay for Circulating Tumor DNA), our blood-based (liquid biopsy) assay to evaluate circulating tumor
`DNA, or ctDNA, which is DNA shed from tumors that circulates in blood plasma outside of cells, that we commercialized
`in 2016;
`FoundationFocus™ CDx BRCA, a companion diagnostic assay, approved by the U.S. Food and Drug Administration, or
`FDA, to aid in identifying women with ovarian cancer for whom treatment with Rubraca™ (rucaparib) is being considered,
`that we commercialized in 2016; and,
`FoundationOne CDx™, the first FDA approved broad companion diagnostic assay for solid tumors. FoundationOne CDx
`was approved by the FDA on November 30, 2017 as part of a parallel review process for breakthrough devices with FDA
`and The Centers for Medicare and Medicaid Services, or CMS.
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`To accelerate our commercial growth and enhance our competitive advantage, we are continuing to innovate and commercialize new
`molecular information services for physicians and biopharmaceutical companies, pursue reimbursement from regional and national
`commercial third-party payors and government payors, strengthen our commercial organization, introduce new marketing, education,
`provider, policy, and advocacy engagement efforts, seek inclusion of molecular information services into oncology clinical care treatment
`guidelines published by accredited cancer care organizations, grow our molecular information knowledgebase, called FoundationCore,
`expand global access to our molecular information services through our broad collaboration with affiliates of Roche Holdings, Inc., or
`Roche, publish scientific and medical advances, broaden our collaborations with biopharmaceutical companies, particularly in the areas of
`biomarker discovery, targeted and immuno-oncology, and companion diagnostics development, and foster relationships across the global
`oncology community.
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`The Shift to Personalized Cancer Care
`The cancer treatment paradigm is evolving rapidly, and we believe there is now widespread recognition that cancer is a disease of
`the genome, rather than a disease defined solely by its specific anatomical location in the body. Today, physicians increasingly use
`precision medicines to target cancers based on the specific genomic alterations driving their growth. Furthermore, in May 2017, the
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`FDA granted its first tissue/site-agnostic approval. We believe this signals the potential for additional FDA approvals based on the
`presence of genomic biomarkers as opposed to the anatomic location of the cancer.
`We believe physicians need molecular information about their patients’ unique cancers to determine the optimal course of treatment.
`We also believe the oncology community needs comprehensive molecular information services that can assess the known
`biologically relevant genomic alterations and cancer biomarkers from a patient’s disease and distill complex molecular information into a
`concise and actionable format. We designed our suite of clinical molecular information services to meet these needs. We believe a CGP
`approach to providing molecular information for use in clinical settings addresses an area of significant unmet medical need for patients
`suffering from advanced, or active metastatic, cancers. We estimate that there are approximately 1.1 million patients per year in the United
`States with newly-diagnosed or recurrent, active metastatic cancers who fall into challenging treatment categories, including patients who
`have rare or aggressive diseases, patients whose disease has progressed after standard treatments, and patients who have tested negative
`under, or been ineligible for, traditional molecular diagnostic tests. We are initially focusing on these patients because we believe this
`patient population will benefit most from our comprehensive molecular information products.
`To maintain our market leadership position and offer physicians and the biopharmaceutical industry a full suite of innovative
`molecular information services, we continue to innovate new molecular information tests and services that can help advance personalized
`cancer care. For example, in November 2017, we announced FDA approval and receipt of a preliminary NCD from CMS for
`FoundationOne CDx, the first FDA-approved broad companion diagnostic for solid tumors. FoundationOne CDx is the next evolution of
`our flagship assay, FoundationOne. FoundationOne CDx provides physicians with a clinically and analytically validated platform to help
`guide treatment decisions and enable efficient patient access to targeted therapies, immunotherapies, and clinical trials. By enabling
`physicians to use a single, FDA-approved companion diagnostic assay for multiple drugs requiring a companion diagnostic, we believe we
`can reduce much of the guesswork that often arises when selecting a diagnostic test for cancer. Our approach is designed to help assure
`physicians and their patients that they have the information necessary to make an informed treatment decision based on a comprehensive
`view of companion diagnostic claims, as well as potential treatment options based on oncology clinical care guidelines, peer-reviewed
`literature, and clinical trial options.
`At the time of its approval, FoundationOne CDx guided to 17 targeted therapies across five of the most common solid tumors:
`NSCLC, CRC, ovarian cancer, breast cancer, and melanoma. FoundationOne CDx also reports predictive genomic signatures for immuno-
`oncology treatment selection including microsatellite instability (MSI) and tumor mutational burden (TMB). We intend to update
`FoundationOne CDx over time with new FDA-approved companion diagnostic claims. As such, we believe FoundationOne CDx enables
`the practice of precision oncology by identifying more patients who may benefit from targeted treatment, immunotherapy approaches, and
`clinical trials than traditional single gene testing methods.
`FoundationOne CDx was approved by the FDA and granted a preliminary NCD by CMS as part of a process called Parallel Review
`for breakthrough devices. Concurrent with our FDA approval, we received a preliminary NCD from CMS. The preliminary NCD proposes
`to cover FoundationOne CDx for Medicare beneficiaries and for individuals with Medicare Advantage plans who meet the eligibility
`criteria outlined in the to-be-finalized coverage policy. We received our unique PLA billing code for FoundationOne CDx in February
`2018 and expect to commercialize FoundationOne CDx in early 2018.
`As the number of available targeted therapies and immunotherapies expands and as physicians gain further experience using
`comprehensive molecular information in their routine treatment decisions, we believe that the potential addressable market for
`comprehensive molecular information services will expand over the next five years to include most patients who have metastatic disease
`and additional patients with earlier stage disease, to identify patients with predictive tumor biomarkers for whom immunotherapy may
`provide the best course of treatment, and for liquid biopsy services for patients from whom a tissue biopsy is not available. We estimate
`that this potential market expansion could bring the total number of patients who could benefit from our approach in the United States to
`approximately two million annually.
`The use of personalized medicine in oncology is continually evolving, and we believe the understanding of the genomic changes in
`each patient’s tumor DNA is enabling a shift in clinical treatment from a one-size-fits-all approach to one that is highly individualized
`based on comprehensive molecular insights. As such, the biopharmaceutical industry is accelerating research and development of targeted
`therapies and immunotherapies. For example, we believe there are more than 630 targeted therapies and immunotherapies for cancer care
`in late-stage clinical development by biopharmaceutical companies, as well as thousands of open and enrolling clinical trials ongoing in
`the United States. To keep pace with this shift to personalized cancer care, there is an increasing focus on the use of companion diagnostics
`to guide physicians in selecting the most appropriate therapy for each patient, and a desire to accelerate biopharmaceutical development of
`new, innovative therapies.
`We believe FoundationOne CDx, along with our full suite of molecular information services, provides us with significant
`competitive differentiation and a first-mover advantage in our biopharmaceutical and clinical businesses. FoundationOne CDx provides
`our biopharmaceutical partners with an FDA-approved platform for companion diagnostic development which may mitigate
`developmental, operational, and commercial risks in companion diagnostic development. FoundationOne CDx received FDA approval that
`included companion diagnostic claims for 17 targeted therapies indicated for treatment in five of the most common solid tumor types. Over
`time, we expect to expand the number of companion diagnostic claims approved by the FDA on FoundationOne CDx. For
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`example, we have announced that we are developing companion diagnostics to be included on FoundationOne CDx for several of our
`partners including AstraZeneca PLC, or AstraZeneca; Pfizer, Inc., or Pfizer; and Roche.
`As a precursor to the FDA approval of FoundationOne CDx, in December 2016, we received FDA approval for, and began
`commercialization of, FoundationFocus CDx BRCA, a companion diagnostic assay to aid in identifying women with ovarian cancer for
`whom treatment with Rubraca™ (rucaparib), a therapy offered by Clovis Oncology, Inc., or Clovis, is being considered. This companion
`diagnostic claim is now included on FoundationOne CDx. We believe the experience of gaining FDA approval for FoundationFocus CDx
`BRCA was instrumental in our FDA approval for FoundationOne CDx.
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`Our Unique and Synergistic Business
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`We believe we have a unique and synergistic business model comprised of:
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`A robust clinical business providing molecular information to physicians;
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`A strong biopharmaceutical business where our molecular information services enable us to serve as a powerful research
`and development partner; and
`Bioinformatics and data analytics capabilities that enable us to provide molecular insights that inform our partners’
`development strategies.
`Each facet of our business enables us to continually innovate and update our molecular information services so that all patients with
`advanced cancer have access to personalized care.
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`•
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`We are dedicated to ongoing innovation of our molecular information platform and new product pipeline. Through our synergistic
`business model that incorporates broad biopharmaceutical partner relationships, we have a unique opportunity to generate revenue and to
`provide insights into new cancer genes and important biomarkers under investigation. These new genes and biomarkers can then be
`incorporated into our molecular information platform at an early stage and allow us to participate in the development of the newest
`oncology therapeutics and clinical practice.
`For example, our efforts have yielded enhancements to our CGP platform over time:
`•
`In 2017, we continued to build upon the body of evidence supporting tumor mutational burden (TMB) as a reliable,
`predictive marker of response to immunotherapy. At the 2017 Annual Meeting of the American Society of Clinical
`Oncology, or ASCO, we presented data showing that measuring TMB with FoundationOne can predict responses to FDA-
`approved anti-PD-1/anti-PD-L1 immunotherapies in triple-negative breast cancer, ovarian cancer, metastatic melanoma,
`biliary tract cancer, and cancer of unknown primary, pointing to potentially new subsets of patients who may benefit from
`this therapeutic strategy. This data builds off data previously presented at ASCO 2016 demonstrating that FoundationOne
`may help predict response to cancer immunotherapy agents across a variety of advanced cancers by integrating two
`independent quantitative markers, TMB, and micro-satellite instability, or MSI, as part of the assay. Specifically, TMB
`calculated by Foundation Medicine successfully predicted a greater likelihood of patient response and longer response
`duration to cancer immunotherapies in patients with advanced bladder cancer, metastatic melanoma, and colorectal and
`lung cancers.
`• We further presented new and compelling data at the 2017 Annual Meeting of the American Society of Hematology, or
`ASH, using FoundationOneHeme. One data presentation showed that more than one-quarter of patients with plasma
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`cell leukemia, or PCL, had high TMB indicating the potential for response to immuno-oncology treatment strategies,
`including checkpoint inhibitors. Currently, less than 50 percent of PCL patients achieve complete remission with current
`standard of care treatments, underscoring the need for new treatment options for these patients and the importance of
`measuring TMB as part of genomic profiling.
`At the 2017 European Society for Medical Oncology Annual Meeting, we presented validation data for our novel assay
`measuring tumor mutational burden from blood, or bTMB. The data presented was from a retrospective analysis
`from Roche/Genentech's Phase II POPLAR and Phase III OAK studies that enabled analytic and clinical validation for our
`bTMB assay. The studies demonstrate that high bTMB as measured by our novel assay is associated with response to
`atezolizumab in individuals with previously-treated NSCLC, potentially offering a new option to expand personalized care
`options for patients with advanced cancer. Based on these findings, our bTMB assay has been integrated as part
`of Roche/Genentech's prospective, randomized Phase III Blood First Assay Screening Trial (BFAST) as a companion
`diagnostic assay to investigate bTMB as a non-invasive biomarker of response to first-line atezolizumab in advanced
`NSCLC patients. As cancer immunotherapy continues to emerge as a therapeutic tool for patients, there is a significant need
`for a non-invasive measure of TMB in patients where tissue is not available or when a tissue biopsy is not feasible.
`TMB and MSI are reported on all FoundationOne CDx, FoundationOne and FoundationOneHeme cases. We expect further
`development of our bTMB assay as a companion diagnostic, providing an important predictive and complementary solution to add to our
`FoundationACT liquid biopsy platform, and ultimately enabling physicians to make informed selection of targeted or immunotherapy
`treatments if tissue is unavailable.
`We believe we have a significant first mover advantage in building a compelling portfolio of molecular information services that
`comprehensively assesses cancer simultaneously for immunotherapy biomarkers such as MSI and TMB as well as for four classes of
`genomic alterations (i.e., base pair substitutions, copy number alterations, short insertions and deletions, or indels, and gene
`rearrangements) across all cancer-related genes with the sensitivity and specificity required for routine medical practice. We continually
`publish or present our analytic validation to demonstrate the accuracy and reliability of our assays. For example:
`
`•
`FoundationOne: Our analytic validation for FoundationOne was published in Nature Biotechnology in October 2013.
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`•
`FoundationOneHeme: Together with our partner, Memorial Sloan Kettering Cancer Center, we published our analytic
`validation for FoundationOneHeme in the journal Blood in 2016.
`FoundationACT: We presented analytic validation data for FoundationACT in the 2016 Advances in Genome Biology and
`Technology, or AGBT, Conference and at the 2016 Annual Meeting of the American Association for Cancer Research, or
`AACR, demonstrating that our platform achieves high unique coverage for our test from limited ctDNA input which
`enables accurate detection of base substitutions, indels, and genomic rearrangements at very low tumor content, as well as
`copy number amplifications with performance specifications equivalent to those for FoundationOne. Subsequently, we
`submitted a manuscript for publication.
`FoundationFocus CDx BRCA: FDA approved based on analytic and clinical validation.
`FoundationOne CDx: We presented analytic validation data for FoundationOne CDx at the 2017 International Association
`for the Study of Lung Cancer, or IASLC, 18th World Conference on Lung Cancer, or WCLC. Data demonstrated high
`concordance with multiple companion diagnostics and other single marker assays currently used to match targeted therapies
`to people with certain types of NSCLC, melanoma, CRC, ovarian cancer or breast cancer.
`We believe the genomic alterations identified for each patient by our CGP assays should be accompanied by the most current and
`relevant scientific and medical literature related to those alterations, and that this information should be presented in a clear and concise
`manner to enable informed clinical treatment decisions and to facilitate development of novel therapeutics. Our molecular information
`knowledgebase, FoundationCore, amasses genomic alteration data from every tumor sequenced with one of our CGP assays, combined
`with a highly curated database of clinical findings and evidence associated with these genomic results. We have sequenced approximately
`180,000 sample profiles as of December 31, 2017, representing more than 150 tumor types, and we believe FoundationCore is the largest
`real-world cancer genomics database of its kind. Our test reports contain combined genomics information with scientific and medical
`literature specific to the identified genomic alterations detected in a patient’s tumor. These patient reports are available to ordering
`physicians through our Foundation Portal (formerly our Interactive Cancer Explorer, FoundationICE).
`In an effort to leverage molecular insights to advance personalized cancer care, we are working to match patients to clinical trials
`based on the genomics of each patient’s unique cancer. Clinical trials often provide opportunities for patients to access targeted therapies
`and immunotherapies, yet it is estimated that only 3%-4% of patients with cancer in the United States are enrolled in clinical trials. We
`believe our unique and proprietary decision support applications are a competitive differentiator of our comprehensive molecular
`information solutions. They may accelerate the adoption of our molecular information services and potentially enable greater patient access
`to personalized medicine. One example is our innovative program called FoundationSmartTrials, which includes a suite of offerings to
`help increase patient access to, and provider awareness of, clinical trials, and, in doing so, accelerate drug development for our
`biopharmaceutical partners.
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`One such offering in our FoundationSmartTrials program is called Precision Enrollment, which efficiently identifies patients with
`rare or specific biomarkers and matches them to clinical trials. A second offering in FoundationSmartTrials is our Recruiter tool which is
`optimized for early-stage trials or trials with broader target profiles. This service identifies qualified patients for potential enrollment at the
`same institution where they are being treated. We have developed, and are now piloting, additional offerings within the
`FoundationSmartTrials portfolio. We believe our FoundationSmartTrials program may be a catalyst for precision medicine by enabling
`greater patient access to personalized therapies and simultaneously enabling our biopharmaceutical partners to accelerate drug
`development due to optimized patient identification and trial enrollment, while building the necessary evidence base to guide clinical
`decision-making. We believe the combination of our CGP assays, our FoundationCore knowledgebase, our robust data analytics programs,
`and our deep and extensive biopharmaceutical relationships uniquely position us to make a significant impact on patient enrollment in
`oncology clinical trials nationwide.
`We have observed significant adoption of our clinical molecular information products in the marketplace, and many thousands of
`physicians from large academic centers to community-based practices have ordered our molecular information products for clinical use.
`We believe this breadth of adoption demonstrates the demand for and utility of our comprehensive genomic profiling solutions that help
`oncologists effectively implement the promise of precision medicine.
`We believe our suite of molecular information services have a sustainable competitive advantage because they:
`•
`Provide comprehensive and reliable identification of clinically relevant information — FoundationOne currently assesses
`315 biologically relevant cancer genes for all four classes of genomic alterations clinically relevant to the treatment of cancer,
`including TMB and MSI, with high sensitivity and specificity. We believe FoundationOne identifies genomic alterations that
`many other commercially available “hot spot” diagnostic tests cannot. FoundationOneHeme employs RNA sequencing of
`265 genes in addition to DNA sequencing of 406 genes to detect all classes of genomic alterations, including TMB, across
`genes known to be altered (other than through inherited genetic characteristics), which are also known as somatic alterations,
`in hematologic malignancies, and in advanced sarcomas, which we believe also will lead to the identification of clinically
`relevant information. FoundationACT identifies in a cancer patient’s blood all known clinically relevant alterations in 62
`genes altered in human solid tumors that are validated targets for therapy or are unambiguous drivers of cancer. The assay has
`been optimized to overcome the tremendous challenges of detecting low quantities of ctDNA in blood and has been
`analytically validated for high accuracy across all classes of genomic alterations clinically relevant to the treatment of cancer.
`FoundationFocus CDx BRCA is the first FDA-approved, tissue-based, genomic assay based on next generation sequencing
`that detects tumor BRCA1 and BRCA2 mutations (which may include both germline (inherited) and somatic (acquired)
`mutations) in women with ovarian cancer. FoundationOne CDx is the first FDA-approved broad companion diagnostic assay
`for solid tumors. FoundationOne CDx currently assesses 324 relevant cancer genes for all classes of genomic alterations, and
`reports on TMB and MSI. FoundationOne CDx has demonstrated proven concordance with multiple FDA-approved
`companion diagnostic assays and FDA approval is based on analytical and clinical validation of more than 6,300 samples.
`Offer a portfolio approach providing oncologists with important options in CGP testing — We believe we are the only
`provider of both tissue and liquid biopsy CGP, together with a full range of molecular information products and companion
`diagnostics for solid tumors and hematologic malignancies. We believe physicians appreciate the ease-of-use and simplicity
`of ordering from one company that provides a full solution for all CGP testing.
`Eliminate Barriers to Patient Access — FDA-approved FoundationOne CDx provides physicians with a single validated,
`high quality test that looks for all guideline-recommended genes i