Leveraging the Power of Proteins to Deliver Precision Health - 2020 Management Presentation - SomaLogic
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
Safe Harbor Statement Some of the statements in this presentation constitute forward-looking statements. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “seek,” “believe,” “intend,” “plan,” “estimate,” “pro forma,” “anticipate,” “predict,” “project,” “potential,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Examples of these statements include, but are not limited to, statements regarding the following: our projected future spending plans and operating results, our tests’ potential clinical utility and advantages over competitive offerings, market opportunities for current and planned tests, market adoption of current and planned tests, development of enhanced and new tests, potential additional applications for data generated by our tests, our go-to-market strategy, potential reimbursement or payor coverage for our tests, cost reduction efforts, sales productivity, intellectual property protection, potential out- licensing or spin-out transactions, upside opportunities, our future capital needs and the timing and availability of additional financing. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These statements involve substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. These statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. As a result of these factors, actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. The forward-looking statements in this presentation represent our views as of the date of this presentation. We anticipate that subsequent events and developments will cause our views to change. We undertake no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this presentation. © 2020 SomaLogic, Inc. All rights reserved. 2
Who We Are As the global leader in commercial protein measurement and interpretation, we are transforming biomedical discovery, clinical diagnostics and disease management and personal health. 3
Key Investment Highlights Addressing ~$6B Market Opportunity in Biopharma / Research & Self-Pay, with Longer- Term Potential to Tap Into ~$50B U.S. Based TAM Through Risk-Bearing and DTC Core Technology Advanced Over ~20 Years, with $365M+ of Equity Investment Strong Strategic and Business Relationships with Blue Chip Pharma & Biotechs Robust Product Pipeline of 100+ Health, Wellness and Disease Management Tests with Near-Term Commercial Potential Compelling Growth Profile with Highly Visible Contracted Revenues Seasoned Leadership Team 4
Seasoned Leadership Team MANAGEMENT Roy Smythe Melody Harris Matt Norkunas Patrick Terry Nebojsa Janjic Stephen Williams Alan Williams Fintan Steele Chief Executive President and Chief Chief Financial Chief Commercial Chief Science Chief Medical Chief Development Chief, Officer Operating Officer Officer Officer Officer Officer Officer Communications BOARD OF DIRECTORS Charles M. Lillis Terry L. Randall Former Chairman & CEO, Media One Group; President & CEO, Heritage Capital Larry Gold Co-Founder & Managing Partner, LoneTree Capital Alister (Al) W. Reynolds Chairman & Anne Margulies Former SVP of U.S. Operations, Quest Diagnostics Founder of Vice President & Chief Information Officer, Harvard University Roy Smythe SomaLogic Jessica Mathews CEO, SomaLogic; Former CMO for Strategy & Partnerships, Former President, Carnegie Endowment for International Peace Royal Philips Franck J. Moison Former Vice Chairman, Colgate-Palmolive Richard Post Former President & CEO, Autobytel, Inc. 5
SomaLogic: Driving the Proteomic Revolution BioPharma Concierge Medicine Life Science Research Self-Pay Executive Health Academic Alternative Health Health Systems Insurers Risk-Bearing Direct-to-Consumer (DTC) National Health Services VALIDATED WITH PARTNERS, PATIENTS, PUBLICATIONS, EXISTING BIOPHARMA, ACADEMIC BUSINESS AND DATABASE ~80 ~250 ~300,000 ~700 Patents ~$32M Partners Publications Cumulative Samples (Issued and Pending) Revenues (2019) Established Market Future Market 6
Why Proteins? ▶ Proteins are the best source of available biological information for health, wellness and disease management ▶ Proteins mediate the effects of all known drugs DNA Unique hereditary material that encodes biological molecules Proteins Functional and structural molecules for all biological processes mRNA Receptors b ind Molecule that Unlike Genes — Proteins are Contextual carries the “directions” for While the genome stays the same, each human protein synthesis proteome is dynamic — protein levels within the body are constantly changing 7
Addressing The Limitations of Genomics … SOMALOGIC’S PROTEOMIC TESTING PLATFORM ADDRESSES THE LIMITATIONS OF GENOMICS “Traditional” Genomics T-Cell Recognition Cell-Free DNA mRNA Protein Measurement Legacy approaches utilizing Limited to diseases and Limited to diseases and Limited applications, Covers all human biology in next-gen sequencing conditions that activate conditions that shed primarily used as a real-time, across many T-cells marker DNA research tool diseases and health states Few Competitors, Highly Contextual, Many Competitors, Less “Contextual”, Few Diseases and Conditions Many Diseases and Conditions 8
Solving the Commercial Protein Puzzle We can commercially measure ~5x the number of proteins vs. our closest competitor — at a ~10x lower cost per unit Yes Partial ▶ Proven ability to measure ~5,000 No Antibodies Mass Spec. SomaLogic Platform (~7,000 in next 12-18 months) proteins Breadth from a single sample input Depth ▶ Capability to run assays simultaneously, at high-throughput — faster, less costly Speed ▶ Established CLIA/CAP-certified lab Cost infrastructure Scalability ▶ Small biological sample volume Reproducibility required Low Sample Size ▶ Highly scalable and reproducible 9
▶ SomaSignal tests are created using machine learning and advanced pattern recognition modeling The SomaLogic Platform ▶ In each model, an individual’s risk is determined by the pattern of expression of between 16 and 300 proteins 1 6 2 7 3 8 4 9 5 “SOMAmer” SomaScan SomaScan SomaLogic SomaSignal reagents Assay Discovery Alliance Proteomics Database Tests Slow Off-Rate Incorporates ~5,000 (current) Access to World-Leading Modified(“SOMAmer”) unique SOMAmer reagents Biobanks Supports High- Aptamers: proprietary to measure proteins in a Quality Database protein-binding reagents single sample SELF-PAY, RISK-BEARING AND DTC MARKETS 1 4 7 10
How To Transform Healthcare with a Proteomics Dx Platform Achieve dramatically 1 6 better health, wellness and 2 7 disease 3 8 outcomes 4 9 5 COMPLETELY NOVEL MORE FEASIBLE LESS EXPENSIVE Measure ~5X+ MORE more proteins at ~10x lower CONVENIENT per unit cost… LESS INVASIVE Ø SomaSignal tests have a transformational ability to Then develop identify individuals thought to be at “no risk” for a diagnostic tests that are… condition who actually are — and those “optimally treated” for conditions, with residual significant risk Ø This information is currently not available to clinicians 11
Proteomic Testing vs. Genetic Testing Genomic tests: “one and done.” Re- doing genetic tests over time usually will not give any indication of changing condition or disease risk. X (one) Proteomic tests: can be repeated over time - to understand if a biologic condition or disease risk is changing. X (many) The “cost” incurred by SomaLogic for delivering more than one test at a time is simply running a different algorithm 12
Robust Commercial Product Pipeline of 100+ Tests Any test, or combination of all available tests can be run on any patient from one biological sample Launched (Q4:2019) Available 2020-2021 Available 2022+ Preventative Disease Preventative Disease Preventative Medical Management Medical Management Medical Primary CV risk – 4 year NASH: 4 liver biopsy components eGFR (kidney function) CHF therapy sensitivity CV risk (all-comers Secondary CV risk – 4 year Cancer susceptibility (top 4) Predict type II diabetes Cancer early detection multiple subtypes) Liver fat Kidney disease prognosis diagnosis with COPD risk/risk of Cancer risk (top 15) Glucose tolerance Congestive heart failure complications progression Functional status/ability prognosis Pulmonary function w/aging GLP-1 agonist response Congestive heart failure type Coronary artery calcium Rule-out symptomatic coronary surrogate heart disease Statin adherence Health/Wellness Health/Wellness Health/Wellness Resting energy rate Healthspan Physical activity Circadian cycle Mental stress Cardiorespiratory fitness/VO2 max Lifespan Body weight trajectory Reproductive health Inflammatory load Alcohol impact Sleep quality Bone mineral mass Cognitive trajectory Microbiome diversity Body fat percentage Alzheimer's/dementia risk Insulin sensitivity Depression/mood Diet change/hypertension Visceral fat Cognitive function w/aging correlation Lean body mass Biologic/functional age Frailty Joint health Social deprivation Grip strength w/aging Smoking status 13
World-Class Academic and Strategic Partnerships ▶ Research partnerships that have advanced the scientific platform ▶ Client collaborators that fund the development of the world’s largest human proteomics database The NASH Consortium ▶ Key vendor relationships for supply chain and capacity growth ▶ Third-party key opinion leaders now positioned and in-place ▶ Long-term relationships that will facilitate clinical utility work and business development Denotes revenue-generating client collaborator. 14
SomaScan Discovery Alliance Self-Pay Risk-Bearing DTC Unlocking the Applied Market Opportunity of Proteomics SomaScan SomaSignal Discovery SomaSignal SomaSignal Product Alliance Self-Pay Risk-Bearing Direct-to- Consumer (SDA) (DTC) 2017 SomaSignal 2019 2022 2023 Translation 2020 ~$900M TAM* ~$4B ~$14B ~$30.5B to ~$2B BioPharma and Concierge Medicine, Health Systems and Direct-to-Consumer Academic Markets Executive Health and National Health Alternative Health Services Insurers *Source: LEK market research estimates (U.S.- only) 15
SomaScan Discovery Alliance Self-Pay Risk-Bearing DTC Enables Key Insights for BioPharma and Academic Markets ▶ Market size estimated at ~$900M to ~$2B* • Biologic drug efficacy and risk Clinical Trials BioPharma • Drug impact on disease biology, trial inclusion • Wet laboratory-based protein targeted drug Drug Discovery development SomaScan • In vivo animal studies for drug development Discovery Genomic / • Use of GWAS and SNPs to find secondary drug targets Alliance Proteomic Studies • Fine phenotyping (pQTL) for drug targeting and (SDA) disease understanding SomaSignal Translation Companion Dx • Development of companion diagnostics 2020 Academic Basic / Translational Research • Unlocking preclinical biologic insights across a broad spectrum of protein-based investigative areas SomaScan SomaScan Access Proteomic Data Participant SomaScan Access Individual Participant Clinical Data *Per LEK market research (U.S.- only) 16
SomaScan Discovery Alliance Self-Pay Risk-Bearing DTC Novartis: Transformative 10 Year Deal for SomaLogic ▶ Long-term, committed partner (since 2011) ▶ Renewed 10-year collaboration in March 2019: • Sample commitments of >250K (run on SomaLogic Platform), in aggregate, over the next several years • Novartis to invest ~$50M in this current funding round ▶ Plan to use SomaLogic’s technology platform for all pipeline drug development programs ▶ ~1/3 of total revenues for the next ~2 years are highly visible, contracted revenues ▶ Other, similar large deals are in late-stage development 17
SomaScan Discovery Alliance Self-Pay Risk-Bearing DTC SomaSignal Tests: Transformational Dx Platform for Self-Pay ▶ Market size estimated at ~$4B* • Replace invasive, expensive, COMMERCIAL LAUNCH UNDERWAY (AS OF Q4:2019) inconvenient existing tests Dx Testing • Test across multiple conditions and risks simultaneously Primary Secondary Cardiovascular Risk Cardiovascular Risk • Deployment of some tests not previously available Cardiorespiratory SomaSignal Patient Risk • Use of individual biology to much Liver Fat Fitness Stratification more accurately risk stratify Self-Pay Body Fat Lean Body Percentage Mass • More accurate and rapid Physician assessment of patient “intervention” need — to + Glucose Tolerance, Resting Productivity Alcohol Impact streamline efficiency of care Energy Rate and Visceral Fat PROOF OF CONCEPT STUDY (DECEMBER 2019) VALUE PROPOSITION FOR PATIENTS AND PROVIDERS IN SELF-PAY Nature Medicine: plasma samples on nearly ~17K Overview Booklet Test report patients using SomaScan platform Patient’s personalized SomaScan to assess 11 and SomaSignal tests results health and disease states *Per LEK market research (U.S.- only) 18
SomaScan Discovery Alliance Self-Pay Risk-Bearing DTC Markets in Development: SomaSignal Risk-Bearing and SomaSignal DTC All of the individual physician benefits, plus the ability SomaSignal Population Health to inform health system, national health service and Risk- Management and payor precision population health, and guide Bearing Resource Allocation resource use with data never before available SomaSignal Becoming the leading-edge provider of individual The Democratization health, wellness and disease information to power Direct-to- of Health Information and capture the increasing trend and demand for for Individuals Consumer democratization of healthcare information and technology 19
Proof Of Benefit For Clinical Market Acceptance ▶ SomaSignal tests benefits not requiring intensive study • Identification of patients at risk with no known risk factors for disease who are actually at risk • Identification of patients under “optimal treatment” who are still at significant risk despite treatment • Identification of patients who are candidates, or not, for certain therapeutics ▶ > 250 peer-reviewed manuscripts ▶ Proof of Benefit Studies ▶ 2019 Nature Medicine Paper • Negotiating with health systems currently to demonstrate - plasma samples on ~17K health economics benefits, or physician/patient activation patients to assess 11 health and disease states, provides • A number of tests on the SomaSignal test menu that will allow “scientific underpinnings” for us to do these studies over a period of months, rather than SomaSignal tests years (e.g., CHF hospitalization risk, likelihood of a positive ▶ Trials to prove that workup for ambulatory chest pain, etc.) SomaSignal tests “work” will likely not be necessary on a large scale 20
Well-Formulated Regulatory Approach ▶ SomaScan Assay • Will pursue FDA clearance as De Novo Platform / Assay Tool (e.g., Illumina MiSeq) • Will only need to file updates as content increases or assay platform substantially changes • Will maintain CAP / CLIA certification for RUO and LDT where applicable ▶ SomaSignal Tests • Will seek “modular” approach (similar to Apple and others) • Will file de novo clearance for 1-3 SomaSignal tests as 510k Software as a Medical Device (SaMD) • Subsequent filings will use SaMD Special Controls, rather than entire re-approval process ▶ Regulatory Strategy • Short-term goal is clinical acceptance in Risk-Bearing SomaSignal market and DTC SomaSignal clearance à direct reimbursement facilitation • Not seeking near-term third-party payment for most SomaSignal tests, as pipeline has >100 tests • Will encourage bundled purchase of tests from Risk-Bearing SomaSignal market in capex fashion • Will likely seek payment for some tests involved in “complex” guidelines (e.g., cancer biologic therapy response prediction) later Initial FDA filing on SomaScan Assay (platform) + ~1-3 initial tests anticipated in 1H:2021 21
Proprietary, Expanding High-Quality Proteomics Database ~300k samples run on the assay to-date and anticipated to have ~2M cumulative samples by 2024 ▶ Rigorously curated: enables advanced understanding of the proteome and SomaSignal tests development (including regulatory filing preparation) ▶ Powerful asset and substantial source of value over time, as broader dataset is implemented on incremental biopharma partnerships and FDA filing (in 1H:2021) ▶ Multiple monetization opportunities – curated access to discovery market customers, development of recommendation engines, development of clinical decision support products, among others 22
SomaLogic: Driving the Proteomic Revolution SomaScan SomaSignal Discovery Alliance: Self-Pay: Transforming Drug Release of First Tranche of Development and Disease Protein Pattern-Based Medical Understanding, Yielding a Dx Tests (in 2019) for Precision Growing Consumables and Health, Wellness and Disease Solutions Business Insights SomaSignal Core Technology Risk-Bearing: Advanced Over ~20 Years, The Ability to Inform Health with ~$365M+ of System and Payor Precision Population Health with Data Equity Investment Never Before Available (beginning in 2022) SomaSignal DTC: Strong Strategic and The Leading Edge Business Relationships Provider of Democratized with Blue Chip Healthcare Information Pharma & Biotechs Directly to Individuals (beginning in 2023) 23
You can also read