UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): |
(Exact name of Registrant as Specified in Its Charter)
(State or Other Jurisdiction |
(Commission File Number) |
(IRS Employer |
||
|
|
|
|
|
|
||||
|
||||
(Address of Principal Executive Offices) |
|
(Zip Code) |
||
Registrant’s Telephone Number, Including Area Code: ( |
Not applicable |
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
|
|
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|
|
|
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
|
|
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
|
|
|
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
|
|
Trading |
|
|
|
|
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
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. ☐
Item 7.01. Regulation FD Disclosure.
On August 18, 2022, 23andMe Holding Co. posted the presentation attached as Exhibit 99.1 to this Current Report on Form 8-K to its Investor Relations website at investors.23andme.com, which information is incorporated herein by reference.
The information in this report furnished pursuant to Item 7.01, including Exhibit 99.1 attached hereto, shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. It shall not be deemed to be incorporated by reference into any of the Company’s filings under the Exchange Act or the Securities Act of 1933, as amended, whether made before or after the date hereof and regardless of any general incorporation language in such filings, except to the extent expressly set forth by specific reference in such a filing.
The website address set forth above is included as an inactive textual reference only. The information contained on the website referenced herein is not incorporated into this Current Report on Form 8-K.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits.
Exhibit No. |
Description of Exhibit |
|
|
|
|
99.1 |
|
|
|
|
|
104 |
|
Cover Page Interactive Data File - the cover page interactive data file does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document |
|
|
|
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
|
|
|
23ANDME HOLDING CO. |
|
|
|
|
Date: |
August 18, 2022 |
By: |
/s/ Steven Schoch |
|
|
|
Name: Steven Schoch |
Investor Presentation August 2022
Disclaimer Forward-Looking Statements This presentation 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, including statements regarding the future performance of 23andMe’s businesses in consumer genetics and therapeutics and the growth and potential of its proprietary research platform. All statements, other than statements of historical fact, included or incorporated in this presentation, including statements regarding 23andMe’s strategy, financial position, funding for continued operations, cash reserves, projected costs, plans, and objectives of management, are forward-looking statements. The words "believes," "anticipates," "estimates," "plans," "expects," "intends," "may," "could," "should," "potential," "likely," "projects," "continue," "will," “schedule,” and "would" or, in each case, their negative or other variations or comparable terminology, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are predictions based on 23andMe’s current expectations and projections about future events and various assumptions. 23andMe cannot guarantee that it will actually achieve the plans, intentions, or expectations disclosed in its forward-looking statements and you should not place undue reliance on 23andMe’s forward-looking statements. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. These forward-looking statements involve a number of risks, uncertainties (many of which are beyond the control of 23andMe), or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. Investors are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date they are made. Except as required by law, 23andMe does not undertake any obligation to update or revise any forward-looking statements whether as a result of new information, future events, or otherwise. Use of Non-GAAP Financial Measures To supplement the 23andMe’s unaudited condensed consolidated statements of operations and unaudited condensed consolidated balance sheets, which are prepared in conformity with generally accepted accounting principles in the United States of America (“GAAP”), this presentation also includes references to Adjusted EBITDA, which is a non-GAAP financial measure that 23andMe defines as net income before net interest expense (income), net other expense (income), changes in fair value of warrant liabilities, income tax (provision) benefit, depreciation and amortization of fixed assets, amortization of internal use software, amortization of acquired intangible assets, non-cash stock-based compensation expense, acquisition-related costs, litigation settlements not related to normal and continued business activities and expenses related to restructuring and other charges, if applicable for the period. 23andMe has provided a reconciliation of net loss, the most directly comparable GAAP financial measure, to Adjusted EBITDA at the end of this presentation. Adjusted EBITDA is a key measure used by 23andMe’s management and the board of directors to understand and evaluate operating performance and trends, to prepare and approve 23andMe’s annual budget and to develop short- and long-term operating plans. 23andMe provides Adjusted EBITDA because 23andMe believes it is frequently used by analysts, investors and other interested parties to evaluate companies in its industry and it facilitates comparisons on a consistent basis across reporting periods. Further, 23andMe believes it is helpful in highlighting trends in its operating results because it excludes items that are not indicative of 23andMe’s core operating performance. In particular, 23andMe believes that the exclusion of the items eliminated in calculating Adjusted EBITDA provides useful measures for period-to-period comparisons of 23andMe’s business. Accordingly, 23andMe believes that Adjusted EBITDA provides useful information in understanding and evaluating operating results in the same manner as 23andMe’s management and board of directors. In evaluating Adjusted EBITDA, you should be aware that in the future 23andMe will incur expenses similar to the adjustments in this presentation. 23andMe’s presentation of Adjusted EBITDA should not be construed as an inference that future results will be unaffected by these expenses or any unusual or non-recurring items. Adjusted EBITDA should not be considered in isolation of, or as an alternative to, measures prepared in accordance with GAAP. Other companies, including companies in the same industry, may calculate similarly-titled non-GAAP financial measures differently or may use other measures to evaluate their performance, all of which could reduce the usefulness of Adjusted EBITDA as a tool for comparison. There are a number of limitations related to the use of these non-GAAP financial measures rather than net loss, which is the most directly comparable financial measure calculated in accordance with GAAP. Some of the limitations of Adjusted EBITDA include (i) Adjusted EBITDA does not properly reflect capital commitments to be paid in the future, and (ii) although depreciation and amortization are non-cash charges, the underlying assets may need to be replaced and Adjusted EBITDA does not reflect these capital expenditures. When evaluating 23andMe’s performance, you should consider Adjusted EBITDA alongside other financial performance measures, including net loss and other GAAP results. Intellectual Property All rights to the trademarks, copyrights, logos and other intellectual property listed herein belong to their respective owners 23andMe’s use thereof does not imply an affiliation with, or endorsement by the owners of such trademarks, copyrights, logos and other intellectual property. Solely for convenience, trademarks and trade names referred to in this Presentation may appear with the ® or ™ symbols, but such references are not intended to indicate, in any way, that such names and logos are trademarks or registered trademarks of 23andMe. Industry and Market Data This Presentation relies on and refers to certain information and statistics based on 23andMe’s management’s estimates, and/or obtained from third party sources which it believes to be reliable. 23andMe has not independently verified the accuracy or completeness of any such third party information.
Behind Every Data Point Is A Human Being 1
100,000 Our Mission is to Help People Access, Understand, and Benefit from the Human Genome 13.1M1 1.65M 825,000 500,000 366,000 219,000 500,000 REGENERON ALL OF US MILLION VETERAN PROGRAM FINNGEN UK BIOBANK DECODE GENETICS GENOMICS ENGLAND 1 As of June 30, 2022. Size and scale of 23andMe enables rapid, novel discoveries
-15 The net positive score Americans gave the pharmaceutical industry 75% Consumers wish their healthcare experience was more personalized 25% U.S. healthcare spending is waste <12% Probability of success for a drug to be approved, taking ~10 years and costing $2.6B to develop 1 The Healthcare System is Dysfunctional 2 3 4 “Of course our system isn’t about healthcare, it’s about maximizing revenue for a whole bunch of different players that have nothing to do with what’s good for patients.” Elisabeth Rosenthal (Editor-in-Chief, Kaiser Health News) 1 JAMA, “Waste in the US Health Care System” (2019). 2 Redpoint Global / Dynata survey of over 1,000 U.S. consumers (2020). 3 Gallup, “Americans’ Views of U.S. Business and Industry Sectors” (2020). 4 PhRMA, “Biopharmaceutical Research & Development: The Process Behind New Medicines” (2015).
Consumer Scale and Empowerment is the Key to Disrupting Healthcare Media Transportation Hospitality Healthcare “Healthcare cannot change from within, it will need an outside force to change it, and that force will be our customers.” Anne Wojcicki Commerce
We Pioneered Digital DTC Healthcare to Empower Customers With Affordable, Direct Access 2015 Carrier Status (inherited conditions) 2016 GHR (genetic health risk) 2018 PGt (pharmacogenetic metabolism) 2019 MUTYH (colorectal cancer) 2017 BRCA (breast and ovarian cancer) 2020 PGt (pharmacogenetic drug response) Proven accuracy (99% NPV/PPV) and accessibility1 TIME MAGAZINE INVENTION OF THE YEAR 7 FDA Authorizations 1 See FDA De Novo Authorizations 140044, 160026, 170046 and 180028 and FDA 510K Clearances K182784 and K193492. HOXB13 (prostate cancer) 2021
Providing Customers With Key, Actionable Insights “Like me, there are many women who have slipped through the cracks of our current medical screening system, either because they don’t have a family history of breast or ovarian cancer. Or they do not know that they have Ashkenazi Jewish ancestry. In my case, even though I know I have Ashkenazi ancestry, that wasn’t enough to prompt my doctor to consider screening. So there are many women walking around with this risk, who, like me, would have never known of their own risk but for this test from 23andMe.” 23andMe customer who discovered she had a BRCA1 mutation 12,000+ Customers with Hypercholesterolemia (FH) variants 8,000+ Customers with a tested BRCA1 / BRCA2 variant 18,000+ Customers with an increased risk for Chronic Kidney Disease 80% Customers receive a report with a meaningful genetic variant Note: Estimates based on prevalence of variants in 23andMe’s Database as of June 30, 2022.
Transforming Healthcare With 23andMe’s Crowdsourced, Genetic Database 2 “The mission of 23andMe is not just about genetics. We want to transform healthcare...What I have learned after 11 years is that people want to participate in research…They don’t want to be a human subject. They want to be respected as an equal and as a partner in the process.” Anne Wojcicki to Recode Decode (2018)
A C G T We are all 99.5% genetically alike ...is a data problem, a very big data problem Unlocking the Genetic Code Creates the Opportunity to Revolutionize the Diagnosis, Prevention and Treatment of Most, if Not All, Human Disease 3 billion base pairs long Cracking the code…
We Are Redefining Healthcare. With Data. At Scale. Enabling Research & Services Empowering Consumers 13.1M Genotyped Customers1 4B+ Phenotypic Data Points2 Developing Therapeutics 50+ Programs2 Cumulative Genotyped Customers (in M, fiscal year ends March 31) FY17A FY18A FY19A FY20A FY21A FY22A 2.0 4.4 7.8 9.8 11.3 12.8 10M+ Genetic Profiles Created Critical Mass 1. As of June 30, 2022. 2. As of March 31, 2022. Programs include collaborated, 100% owned and royalty interest targets. 425K 23andMe+ Subscribers2 FY23Q1 13.1
Novel Consumer Products Drug Discoveries 50+ Programs2 Phenotypic Data 13.1M Genotyped Customers1 Innovative Results Return Value to the Customer We run hundreds of billions of association tests per year that further our unique understanding of human biology Consumer Powered Healthcare Flywheel Consumer Research Therapeutics / Product Data 80% Opt-In to Research 1. As of June 30, 2022. 2. As of March 31, 2022. Programs include collaborated, 100% owned and royalty interest targets. Genetic Data Insights 4B+ Phenotypic Data Points2
Our Ancestry Service A Mass Entry Point to Building a Revolutionary Database DNA Relatives Visualize Genetic Connections With an Automatically Built Family Tree Ancestry Composition Note: Opt-in required for DNA Relatives and Family Tree builder.
How Ancestry Matters In Connection To Your Health Ann M. 23andMe Customer Ann did not know her ancestry origins and would not have been eligible for clinical testing under current guidelines. Ann decided to do 23andMe to learn more about her potential health risks. Based on her 23andMe report, she discovered she had a BRCA1 mutation. Her doctor confirmed the results and she opted to have surgeries to reduce her risk of having ovarian and/or breast cancer. Current clinical guidelines and eligibility for insurance coverage limit BRCA testing to women with a personal or family history of cancer (Robson, 2003) Adult individuals with a BRCA1 or BRCA2 variant 50% 50% Meet NCCN® criteria1 Do not meet NCCN® criteria 80% 20% Identified by healthcare system Missed by healthcare system 45% 21% No first-degree family history of a BRCA-related cancer Did not self-report having Jewish ancestry DTC Testing 1 NCCN is the National Comprehensive Cancer Network® (NCCN®).
Pharmacogenetics Carrier Status Wellness 30+ Including: Type 2 Diabetes (Powered by 23andMe Research) Coronary Artery Disease Uterine Fibroids Migraine MUTYH-Associated Polyposis BRCA1/BRCA2 (selected variants) Health Predispositions1 10 Including: Muscle Composition Genetic Weight Alcohol Flush Reaction Saturated Fat and Weight Sleep Movement Dog & Cat Allergies 40+ Including: Cystic Fibrosis Sickle Cell Anemia Familial Hyperinsulinism (ABCC8-Related) Tay-Sachs Disease Glycogen Storage Disease (Type 1a) 3 Including: SLCO1B1 Drug Transport CYP2C19 Drug Metabolism e.g., citalopram and clopidogrel DPYD Drug Metabolism 2 1. Includes FDA Authorized Genetic Health Risk Reports and Wellness Reports for Genetic Likelihood Powered by 23andMe Research. 2. Wellness information does not require FDA Authorization. Our Health Service The First and Only Multi-Disease DTC Personal Genome Service (PGS) That Includes FDA-Authorized Reports and Provides Personalized Genetic Insights and Tools LIKELY NORMAL FUNCTION LIKELY NORMAL METABOLIZER LIKELY NORMAL METABOLIZER 7 FDA Authorizations
A Meaningful, Engaging (and Fun) Experience Strong Engagement and Trust Drive Longitudinal Data Collection ~80% customers consent to research 4B+ phenotypic data points 180+ published research papers 16
Subscription service that offers additional insights and features to give members even more actionable information to live healthier lives Pharmacogenetics 3 reports (FDA-Authorized) Heart Health Reports Atrial Fibrillation, Coronary Artery Disease, LDL Cholesterol, Hypertension DNA Relatives Advanced filters, access up to 5,000 relatives Polygenic Risk Scores (Powered by 23andMe Research) Rapidly discovering new genetic insights: Cancer risk Reproductive Health Diet Sleep Fitness and injuries Migraines
Transforming Healthcare with Genetic Health Services at Scale 3
Today’s Healthcare System Has Only a Small Impact on Our Health and Well Being 1. Schroeder, SA. (2007). We Can Do Better – Improving the Health of the American People. NEJM. 357:1221-8. Health and Well-being Social & Environmental Factors Impact of Different Factors on Risk of Premature Death1 20% Individual Behavior 40% Genetics 30% Health Care 10%
Genetic Data Helps Drive Behavior Change Eat healthier Set future goals to be healthier Adopt a healthier lifestyle in general Exercise more Get more rest / sleep Stop drinking / drink less Stop smoking / smoke less 76% Report taking a positive health action1 55% 51% 50% 45% 42% 16% 7% 1 Based on 2019 online survey, designed by 23andMe and M/A/R/C Research, of 1,046 23andMe Health + Ancestry customers.
Opportunity for Personalized Healthcare at Scale Practice of Medicine Today Reactive – no customization until symptomatic Proactive – truly individualized from the very beginning
Opportunity to Deliver Genetic Health Services at Scale Personal Genome Service Diagnostics Testing Pharmacy / E-Prescribing Telehealth Wellness Reports Medical Records +
What are Genetic Health Services? Health Predispositions Identifying potential risks then implementing targeted prevention, monitoring, and management Wellness Targeted to help you feel your best Pharmacogenetics Therapeutics that work for you
Online doctor visits Mail order pharmacy All connected using a single technology platform Long-term Engagement The 23andMe Genetic Health Service is Fully Integrated Genetic Insights
Transforming Therapeutic Development With the 23andMe Database 4
$2.6B average cost of drug development3 ~90% failure rate2, 3 7 years average time-to-IND1 Drug Development is Inefficient Limited Use of Genetic Data and Lack of Patient Engagement Constrain Productivity 1. IND = Investigational New Drug Application. fdareview.org, “The Drug Development and Approval Process” (2020). 2. Probability of success for a drug to be approved is estimated to be <12%. 3. PhRMA, “Biopharmaceutical Research & Development: The Process Behind New Medicines” (2015).
Potential to More Efficiently Develop Novel Therapeutics by “Power, Need, and Speed” 1 IND = Investigational New Drug Application. fdareview.org, “The Drug Development and Approval Process” (2020). 2 Probability of success for a drug to be approved is estimated to be <12%. PhRMA, “Biopharmaceutical Research & Development: The Process Behind New Medicines” (2015). 3 Nelson et al., 2015 (Nature Genetics), King et al., 2019 (PLOS Genetics) Pharmaceutical Industry 27 ~4-5 years to IND with current clinical-stage drugs 7 years average time-to-IND1 Targets with genetic evidence have historically had a higher success rate3 ~90% failure rate2 Publications supporting human genetic evidence for approved drug indications Nelson et al., 2015 (Nature Genetics); King et al., 2019 (PLOS Genetics) 23andMe
Our Scale Enables Real-Time Genetics Health Research1 (numbers below represent the number of research participants with the condition indicated) COVID-19 Research (2020) March 16 April 6 June 8 Kicked Off Study Launched Study Preliminary Findings 750K Consumers participated in the COVID-19 study in the first 90 days 1,287,060 COVID-19 study participants Sept. 7 Posted Findings3 1,876,573 High cholesterol 358,275 Type 2 Diabetes 37,853 Type 1 Diabetes 2,355,068 APOE e4 carriers (Alzheimer’s risk) 1,785,456 Depression 85,604 Epilepsy 1,113,057 Asthma 667,019 Eczema 250,764 Psoriasis 634,734 Irritable Bowel 107,126 UC / Crohn’s 64,800 Barrett’s Esophagus 534,696 Arrhythmia 159,135 Coronary Artery 42,836 Pulmonary Embolism 4,528 Idiopathic Pulmonary Fibrosis 9,047 Systemic Sclerosis 7,334 Sarcoidosis 2 1 As of August 2, 2021. 2 As of September 2021. 3 23andMe COVID-19 manuscript live on MedRXiv September 7, 2020. Re-contactable Customers Participate in Health Research 28
GWAS is a statistical analysis of Single Nucleotide Polymorphisms (SNPs), looking To identify differences in frequency between disease cases and controls. SNPs linked with disease will be found at different frequencies in cases versus controls. Association is represented by the level of statistical significance (p-value) of the SNP frequency difference. SNPs can be tested across the genome and mapped to specific regions. Genome-Wide Association Studies (GWAS) Cases Controls GGCCAGCTGGACGAGG GGCCAGCTGGATGAGG Single Nucleotide Polymorphism (SNP)
Number of independent hits p<5e-8 2015 2016 2017 2018 2019 2020 10,000 5,000 0 15,000 20,000 25,000 30,000 35,000 40,000 Example: Number of Osteoarthritis GWAS1 hits dramatically increase as database grows 2016 2017 2021 New programs are identified through GWAS1 hits, which increase as size of database grows 1 GWAS: Genome-Wide Association Study. Size and Scale Accelerate Target Discovery
Cancer Endocrine Hematology Autoimmunity Allergy Infectious Disease Cardiovascular Orthopedic Ophthalmology Neurology G.I. Metabolic Disease NAFLD (Non-Alcoholic Fatty Liver Disease) Hundreds of Distinct Clinical Phenotypes Across Major and Rare Diseases Phenotype Cases Controls Hits New Lost 48048 2517644 104 44 2
Genetic Association of the TSLP Signalling Pathway With Asthma TSLP JAK2 JAK1 STAT5 TSLPR IL-7R𝝰 Proinflammatory signaling Cell membrane TSLP is a well-known cytokine with a role in maintaining immune homeostasis and regulating inflammatory responses at mucosal barriers. The TSLP signaling pathway is an attractive therapeutic target. e.g. Tezepelumab, a TSLP-blocking monoclonal antibody for treatment of asthma. Our genetic data shows that multiple genes within the TSLP pathway associate strongly with asthma.
We Have Generated a Research and Development Pipeline Covering Multiple Therapeutic Areas GSK is solely responsible for the development of GSK6097608 (GSK’608) in later-stage clinical trials. Subject to its successful commercialization, 23andMe is eligible to earn tiered worldwide royalties up to the low double digits. The 50+ programs in the combined therapeutic areas include 100% owned and royalty interest targets as well as those in collaborations. The majority of the programs are in collaboration with GSK. Note: As of March 31, 2022 Immunology Immuno-oncology Phase 2 Data Phase 1 Data Discovery Next Milestone Preclinical Phase 1 Phase 2 Cardiovascular/ Metabolic GSK’6081 (CD96) 23ME’610 (CD200R1) Neurology Immuno-oncology EARLY-STAGE THERAPEUTIC AREAS (multiple programs in each area) 50+ programs2
Breadth of Phenotyping Provides Deeper Genetic Understanding Beyond Single Diseases PheWAS = Phenotype Wide Association Study Every SNP in the genome can be interrogated at >1,000 medically related phenotypes. Besides the role of a gene in a disease of interest, we can use genetics to learn potential indication expansions or possible unwanted toxicities. For TSLP, PheWAS indicates lack of effect in eczema but also highlights potential indication expansion in a rare disease. Rare disease A Asthma
10,000s of Genome-Wide Association Study (GWAS) Hits Determine Disease Associated Genes and Directionality Translational Research to Understand Mechanism Identifying Druggable Targets Assessment of Unmet Need and Competitive Landscape Best Drug Targets Wet lab validated targets progress through standard stages of research toward the selection of preclinical lead molecules and clinical development Phenotypic Data 23andMe’s database yields thousands of GWAS hits Advanced biology and medicinal chemistry guide design of optimal compounds from initial targets Phenotypic breadth provides unique ability to uncover potential safety issues or possible indication expansions Phenome-Wide Association Studies (PheWAS) Reveal Additional Indications and Potential Safety Concerns Genetic Data Systematic, Scalable Research Platform Yields Novel Drug Targets
23andMe Immuno-oncology (I/O) Programs
CD96 (GSK’608) CD200R1 (23ME’610) + others Our I/O Programs Were Identified With ML and AI Applied to Our Proprietary I/O Genetic Signature Cancer Autoimmune Large I/O market with $60B in 2021 sales 23andMe’s proprietary I/O genetic signature developed with ML which also identifies marketed I/O drugs 2021 sales of leading checkpoint inhibitors I/O genetic signature shows opposing effects on autoimmune and cancer phenotypes $17.2B KEYTRUDA $7.5B OPDIVO $2.0B YERVOY We discovered additional targets that have a similar genetic I/O signature
23ME'610 Targeting CD200R1
CD200R1 pathway identified as a critical immune checkpoint with our I/O genetic signature I/O genetic signature shows opposing effects on autoimmune and cancer phenotypes CD200R1 was Identified as a Promising Anti-Cancer Drug Target with 23andMe’s Proprietary Immuno-oncology (I/O) Genetic Signature We discovered that 3 components of the signaling pathway for CD200R1 have a similar genetic signature to other I/O drugs CD200R1 Receptor Immune Immune Cancer Cancer CD200 Ligand DOK2 Protein Genetic Variant in CTLA4 linked with multiple phenotypes in the 23andMe database Immune and autoimmune phenotypes Cancer phenotypes Identified novel immuno-oncology signature around CTLA4. Cancer Immune
CD200R1 is an Immune Checkpoint References: J Virol 2012;86:6246, J Virol 2004;78:7667, J Immunol 2005;175:4441, Structure 2013;21:820, JCI Insight 2018;3:e96836 CD200R1 is an inhibitory receptor expressed on T-cells and myeloid cells CD200 is the only known ligand for CD200R1 in humans and is highly expressed in certain cancers Binding of CD200 to C200R1 decreases the ability of T-cells to recognize and kill cancer cells Several viruses have co-opted CD200 analogues to suppress and evade the host immune response CD200:CD200R1 Signaling
23ME-00610 (23ME’610) Binds with High Affinity to CD200R1 and Inhibits Immunosuppressive Signaling 23ME ’610 is a fully humanized, effectorless, IgG1 antibody against human CD200R1 23ME ’610 binds CD200R1 with high affinity (KD < 0.1 nM) 23ME ’610 blocks CD200 ligand binding to CD200R1, resulting in inhibition of immunosuppressive signaling The restoration of T-cell activity by 23ME ‘610 was demonstrated using in vitro models of the tumor microenvironment No adverse effects of blocking CD200R1 have been observed in nonclinical toxicology studies 23ME’610 Activates T-cell Function by Blocking the CD200R1 Checkpoint *CD200-expressing cell types include tumor, stroma and endothelial IFN, interferon; IL, interleukin
CD200R1 is expressed on tumor-infiltrating lymphocytes (TILs) from The Cancer Genome Atlas (TCGA) CD200R1 expression (using RNAseq data from TCGA) is correlated with several immune cell markers: CD4, CD8, CD45 (shown), and CD11b CD200R1 is co-expressed with antigens or markers that are expressed on lymphocytes seen in most cancer types 1. Clear cell renal carcinoma (KIRC) is shown and was chosen because it had high immune infiltration in the TCGA dataset TCGA, The Cancer Genome Atlas; TILs, tumor infiltrating lymphocytes 1
Inhibition of CD200R1 has the potential to address resistance to anti–PD1 therapies Blocking the CD200R1 pathway enhanced IFNγ production from SEB-stimulated PBMCs compared to isotype control and anti-PD1 in the majority of samples tested PBMCs from each respective patient were incubated with 100 nM of 23ME-00610, anti–PD-1, or isotype control. Cells were stimulated with SEB. IFNγ levels were determined by enzyme-linked immunosorbent assay. Mean biologic triplicates were normalized to isotype control. *P <0.05. PBMC, peripheral blood mononuclear cell; PD-1, programmed death–1; SEB, staphylococcal enterotoxin B.
Genetics-Based Primary Care Phase 1 Study of 23ME’610 in Patients with Locally Advanced or Metastatic Solid Malignancies Abbreviations: AEs: Adverse Events; DLT: Dose limiting toxicity; DOR: duration of response; IV: intravenous; ORR: Objective Response Rate; OS: Overall Survival; PFS: Progression Free Survival; Q3W: every three weeks; RECIST: Response Evaluation Criteria in Solid Tumors; RP2D: Recommended Phase 2 Dose Study Design 1 Phase 1 Openlabel Non- Randomized Multi-center Objectives Genetics-Based Primary Care Patients with locally advanced, unresectable or metastatic solid tumors that have progressed after or are inappropriate for standard therapy Monotherapy Dose Escalation (IV Infusion Q3W) Accelerated Titration 3+3 Cohorts RP2D / MTD Part A (n ≤ 26) Part B (n = 75) Expansion Cohort Expansion Cohort Expansion Cohort Expansion Cohort Expansion Cohort Primary Secondary and Exploratory Part A: Safety (DLTs, AEs) Part B: Efficacy (ORR) Efficacy (ORR [RECIST and iRECIST]), DoR, PFS, OS) and Safety Pharmacokinetics Pharmacodynamic biomarkers
CD200R1 is an immune checkpoint with a strong I/O signature in three components of the pathway 23ME-00610 is a high-affinity, first-in-class, anti-CD200R1 antibody with immune-activating properties, including: Prevention of CD200-mediated suppression of chronically stimulated T cells Enhancement of cytokine secretion from peripheral blood mononuclear cells (PBMCs) isolated from cancer patients Augmentation of PBMC-mediated tumor cell killing CD200R1 expression was observed on tumor infiltrating lymphocytes from The Cancer Genome Atlas, suggesting that this pathway contributes to an immunosuppressive tumor microenvironment. CD200R1 was also expressed in immune checkpoint inhibitor non-responders, indicating that inhibition of the CD200R1 immune checkpoint has the potential to address resistance to anti–PD-1 and anti–CTLA4 therapies The Phase 1 dose escalation study of 23ME‘610 in patients with advanced solid malignancies was initiated in January 2022 23ME'610 Targeting CD200R1: A Genetically-Validated Approach to Anti-Cancer Therapy
GSK6097608 (GSK'608) Targeting CD96
The GSK’608 Program is a Prime Example of the Value 23andMe Brings to Drug Discovery and Development Inhibition of CD96 leads to immune activation and tumor growth inhibition in non-clinical models GSK’608 is a high affinity monoclonal antibody against CD96 GSK’608 is currently being evaluated in an ongoing Phase 1 study In January 2022, 23andMe elected to take a royalty option on GSK’608. As a result, GSK is now solely responsible for the development of GSK’608.
Financials
Investing in Future Growth in a Fiscally Responsible Manner 1 Solid cash position. Cash of $479 million1 supports 23andMe’s plans for significant investment in Therapeutics portfolio and strategic initiatives. 2 Investing in future growth potential. For those business segments expected to drive future growth, including the new genetic health services and our therapeutics business, we plan to focus on the most strategically and financially valuable options and invest appropriately in each. Employing a conservative approach to planning. Recognizing the current uncertainties in the economy and financial markets, we are prioritizing the minimization of Adjusted EBITDA deficit rather than maximizing top-line growth in our Consumer business (PGS and telehealth). 3 1As of June 30, 2022.
Revenue Composition Three Months Ended June 30, Year Ended March 31, FY2023 FY2022 FY2022 (in $M, except percentages) Amount Percentage of Revenue Amount Percentage of Revenue Amount Percentage of Revenue Consumer Services $56 87% $48 81% $222 82% Research Services 8 13% 11 19% 50 18% Therapeutics - - - - - Total Revenue $65 100% $59 100% $272 100%
Consumer Services Revenue Seasonality by Quarter Note: Fiscal year ends March 31. Q1 Q2 Q3 Q4 Full Year FY 2019 28% 19% 18% 35% 100% FY 2020 24% 24% 21% 31% 100% FY 2021 18% 21% 22% 39% 100% FY 2022 22% 20% 21% 38% 100%
Research and Development Expense Three Months Ended June 30, YoY FY2023 FY2022 (in $M, except percentages) Amount Percentage of total R&D expense Amount Percentage of total R&D expense % Change Therapeutics $24 46% $21 47% 15% Consumer and Research Services 28 54% 23 53% 20% Total R&D Expense $52 $44
Sales and Marketing Expense Composition Note: Balances may not add up due to rounding Three Months Ended June 30, FY2023 FY2022 (in $M) Amount Amount Advertising and Brand $21 $9 Personnel-related expenses 6 3 Outside Services, equipment and supplies 1 1 Depreciation and Amortization 3 - Facilities and other OH Alloc 2 2 Total S&M Expense $33 $15
Segment Information and Reconciliation of Non-GAAP Financial Measures Note: Fiscal year ends March 31. Three Months Ended June 30, (unaudited) FY2023 FY2022 (in $K) Amount Amount Segment Revenue Consumer & Research Services $64,513 $59,239 Therapeutics - - Total Revenue $64,513 $59,239 Segment Adjusted EBITDA Consumer & Research Services ($16,997) ($505) Therapeutics (18,465) (18,303) Unallocated Corporate (14,253) (8,467) Total Adjusted EBITDA ($49,715) ($27,275) Reconciliation of Net Loss to Adjusted EBITDA Net Loss ($89,532) ($42,026) Adjustments: Interest (income), net (245) (44) Other (income) expense, net 435 (14) Change in fair value of warrant liabilities - 534 Income tax benefit (254) - Depreciation and amortization 5,104 4,638 Amortization of acquired intangible assets 4,315 - Stock-based compensation expense 30,462 9,637 Total Adjusted EBITDA ($49,715) ($27,275)
How 23andMe Helps People Access, Understand, and Benefit from the Human Genome Personal Genome Service 1. As of June 30, 2022. 2. Includes Health Predisposition, Wellness, Carrier Status and Pharmacogenetic Reports, including those in 23andMe+ subscription service. 3. As of March 31, 2022. 4. Future services currently in development. Genetic Health Services4 Therapeutics + + + 13.1M Genotyped Customers1 50+ Programs3 80+ PGS Reports2 Healthcare services available in all 50 states
Appendix
Nearby genetic variants are correlated with each other. Knowing the variant in one position allows nearby variants to be inferred. E.g. Fill in the blanks: The q***k brown f*x jumps ov*r the **zy dog. The same principle applies in genetics. The process of filling in the gaps is known as ‘genotype imputation’. We type ~650,000 SNPs using our genotyping array, which allows accurate imputation for >35m SNPs in the genome. Genotype imputation is much more cost effective than large-scale sequencing. Whole-genome sequencing ~$1000 / sample. Exome sequencing ~$400 / sample. Imputation < $0.01 / sample We do deploy sequencing in situations where there is a clear benefit over and above imputation (e.g. rare disease). Before imputation After imputation The Vast Majority of GWAS Discoveries Can be Made Without Large-scale Sequencing
23andMe’s Value Proposition 1 Disrupting the Healthcare experience. 23andMe is building a personalized health and wellness experience that caters uniquely to the individual by harnessing the power of their DNA. Integrating Lemonaid Health’s online digital health platform to deliver personalized, prevention-oriented, genetically-based healthcare at scale 2 The world’s premier re-contactable phenotype-linked genetic database. A vast (>13M genotyped customers) proprietary dataset rich with both genotypic and phenotypic (health) information allows insights that unlock revenue streams across digital health, therapeutics, and much more Over 50 identified therapeutic programs validates the approach of developing novel therapeutics using genetic data. One program in clinical development with GSK, one wholly owned program started clinical trials in January 2022. 4 Continuously increasing quantity and quality of phenotypic data. Impressive customer participation provides >4 billion phenotypic data points for unprecedented statistical power to discover new insights into health and potential therapies. 3 6 Solid cash position. Solid balance sheet supports 23andMe’s plans for significant investment in therapeutics portfolio and strategic initiatives 5 Difficult to replicate platform for value creation. The FDA-approved consumer platform, the therapeutics efforts, and the rich database combine to create multiple opportunities for substantial value creation