iSpecimen Inc 8-K, filed Nov 4, 2021
iSpecimen Inc. (ISPC)
About this 8-K
iSpecimen Inc filed this 8-K on November 4, 2021.
Items reported
- Item 7.01: Regulation FD disclosure
- Item 9.01: Financial statements and exhibits
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
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| Item 7.01. | Regulation FD Disclosure. |
Attached as Exhibit 99.1 hereto and incorporated by reference herein is an investor presentation dated November 2021, that has been referenced by iSpecimen Inc., a Delaware corporation (the “Company”) in the Company’s conference call to discuss its third quarter 2021 results and posted on the Company’s website on November 4, 2021 and.
The information in this Item 7.01 and Exhibit 99.1 attached hereto will not be deemed “filed” for 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, nor will it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”) or the Exchange Act, except as expressly set forth by specific reference in such filing.
Forward-Looking Statement
This Current Report on Form 8-K may contain forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act. Such forward-looking statements are characterized by future or conditional verbs such as “may,” “will,” “expect,” “intend,” “anticipate,” believe,” “estimate” and “continue” or similar words. You should read statements that contain these words carefully because they discuss future expectations and plans, which contain projections of future results of operations or financial condition or state other forward-looking information. Such statements are only predictions and the Company’s actual results may differ materially from those anticipated in these forward-looking statements.
There may be events in the future that the Company is not able to accurately predict or control. Factors that may cause such differences include, but are not limited to, those discussed under Risk Factors in the Company’s registration statement and other filings filed with the Securities and Exchange Commission (the "SEC"), including the uncertainties associated with the Company’s lack of profitability, its continued capital needs, its lack of a long operating history, its growth strategy, the COVID-19 pandemic and its continued impact on the business, its technology development plans, and the regulatory environment in which it operates. Forward-looking statements speak only as of the date they are made. The Company does not assume any obligation to update forward-looking statements as circumstances change. The Company gives no assurance that it will achieve its expectations.
You may access the Company’s SEC filings by visiting SEC’s website at http://www.sec.gov. This Current Report does not constitute an offer or invitation for the sale or purchase of securities or to engage in any other transaction with the Company or its affiliates. The information in this Current Report is not targeted at the residents of any particular country or jurisdiction and is not intended for distribution to, or use by, any person in any jurisdiction or country where such distribution or use would be contrary to local law or regulation.
| Item 9.01. | Financial Statements and Exhibits. |
| (d) | Exhibits. |
| 99.1 | Investor Presentation, dated November 2021 |
| 104 | Cover Page Interactive Data File |
SIGNATURE
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 hereunto duly authorized.
Dated: November 4, 2021
| iSPECIMEN INC. | ||
| By: | /s/ Christopher Ianelli | |
| Name: Christopher Ianelli | ||
| Title: Chief Executive Officer and President | ||
Exhibit 99.1
CONNECT. INNOVATE. November 2021 Investor Presentation TRANSFORMING BIOSPECIMEN PROCUREMENT An online marketplace for human biospecimens
This presentation may contain forward - looking statements within the meaning of Section 27 A of the Securities Act of 1933 , as amended, and Section 21 E of the Securities Exchange Act of 1934 , as amended . Such forward - looking statements are characterized by future or conditional verbs such as “may,” “will,” “expect,” “intend,” “anticipate,” believe,” “estimate” and “continue” or similar words . You should read statements that contain these words carefully because they discuss future expectations and plans, which contain projections of future results of operations or financial condition or state other forward - looking information . Such statements are only predictions and our actual results may differ materially from those anticipated in these forward - looking statements . We believe that it is important to communicate future expectations to investors . However, there may be events in the future that we are not able to accurately predict or control . Factors that may cause such differences include, but are not limited to, those discussed under Risk Factors in our registration statement and other filings filed with the Securities and Exchange Commission (the "SEC"), including the uncertainties associated with our lack of profitability, our continued capital needs, our lack of a long operating history, our growth strategy, the COVID - 19 pandemic and its continued impact on the business, our technology development plans, and the regulatory environment in which we operate . We do not assume any obligation to update forward - looking statements as circumstances change . Certain market data information in this presentation is based on management's estimates . We obtained the industry, market and competitive position data used throughout this presentation from internal estimates and research as well as from industry publications and research, surveys and studies conducted by third parties . We believe our estimates to be accurate as of the date of this presentation . However, this information may prove to be inaccurate because of the method by which we obtained some of the data for our estimates or because this information cannot always be verified due to the limits on the availability and reliability of raw data, and the nature of the data gathering process . You may access our SEC filings by visiting SEC’s website at http : //www . sec . gov . This presentation does not constitute an offer or invitation for the sale or purchase of securities or to engage in any other transaction with us or our affiliates . The information in this presentation is not targeted at the residents of any particular country or jurisdiction and is not intended for distribution to, or use by, any person in any jurisdiction or country where such distribution or use would be contrary to local law or regulation . Forward - Looking Statements 2
Christopher Ianelli, MD PhD | Chief Executive Officer, President, and Director Dr . Ianelli has been serving as our Chief Executive Officer, President, and Director since founding iSpecimen in July 2009 . Dr . Ianelli served as Chief Executive Officer of Abkine Pharmaceuticals, Inc . Dr . Ianelli served as Managing Director at Leerink Partners (formerly Leerink Swann), a leading healthcare and life science investment bank, where he managed the expansion and delivery of services and directed strategy to develop new healthcare data and information assets for the firm from August 2003 to March 2008 . Prior to that, Dr . Ianelli was a co - founder and Managing Director of Boston Medical & Scientific Advisors, a healthcare investment research firm . Dr . Ianelli received his Bachelor of Science degree in Biological Sciences from University of Lowell and both his Ph . D . in Immunology and his M . D . from Tufts University . He completed his residency training, including a year as Chief Resident, in Pathology at Brigham & Women’s Hospital and Harvard Medical School . Jill Mullan | Chief Operating Officer, Secretary, and Director Ms . Mullan h as been serving as our Chief Operating Officer since August 2013 , Secretary since November 2012 , Treasurer from February 2017 to June 2021 , and Director since October 2014 . She joined the Company in 2010 as the Vice President of Marketing . From 2003 to 2010 , she was a marketing and business strategy consultant to various technology - based companies including EMC, AppNeta, and Planon Software . From 2000 to 2003 , Ms . Mullan was on the founding team and Director of Marketing at Storigen Systems, a provider of distributed storage networks . She was also employed at Avid Technology from 1996 to 2000 , most recently as a Director of Product Marketing and Management with product responsibility for Avid’s editing product line . Prior to that, she worked at IBM, MIPS, and Hewlett Packard . She graduated with distinction from Cornell University with a Bachelor of Science in electrical engineering and received a Masters of Business Administration from Stanford University with a focus on entrepreneurship and marketing . Tracy Curley | Chief Financial Officer and Treasurer Ms . Curley brings three decades of experience in public accounting and corporate finance for both publicly traded companies and emerging companies like iSpecimen and joined iSpecimen in August 2020 . She came to iSpecimen after over a decade with national accounting firms such as CohnReznick where she focused on serving clients in the middle markets . During her time as a partner in public accounting firms, she was responsible for creating and leading teams to provide audit and consulting services to a growing clientele of private and public emerging growth companies primarily in the technology and life sciences industries . Ms . Curley received her Master of Accountancy and Bachelor of Science in Business Administration with a concentration in accounting from Kansas State University . She also attended the United States Military Academy . She is a certified public accountant licensed in the Commonwealth of Massachusetts . Benjamin Bielak | Chief Information Officer Mr . Bielak has been serving as our Chief Information Officer since June 2018 . He served as the Chief Information Officer at GNS Healthcare, a leading casual machine learning product and services company, from January 2017 to May 2018 and as Director of Academic Technology at Harvard University, from February 2015 to January 2017 . Prior to his work at GNS and Harvard, Mr . Bielak was the Chief Information Officer at Dovetail Health from November 2006 to April 2014 . He previously held roles as Manager of Development and Integration at Boston Medical Center and Senior Manager of Technology at Sapient, a global services company, from December 1997 to July 2005 . Mr . Bielak holds a Masters of Business Administration degree from Bentley University, where his studies focused on change management, and a master’s degree from Boston University in computer science . Management Team 3
Investor Highlights 4 ~200 Healthcare Provider / Supplier Organizations ~400 Customer Organizations 1. Early - stage opportunity with a first mover advantage 2. $3B - $4B global biospecimen market growing at 10 - 15% per year 1 3. Unique two - sided marketplace disrupting the biospecimen procurement process 4. 90% year - over - year revenue growth (FY 2020 vs. FY 2019) and 57% year - over - year revenue growth (9 months 2021 vs. 9 months 2020) 5. Growing data asset that’s a key enabler and differentiator 1 “Sources Cited” page 28
Accelerate scientific discovery in an online marketplace that empowers researchers to instantly search for and gain access to patients, biospecimens, and data across a global network of healthcare providers Our Vision 5
Human Biospecimens are Essential for Life Science R&D Basic Research Biomarker Identification & Validation Drug Discovery & Development Diagnostics Discovery & Validation Biofluids Solid Tissue Stem & Immune Cells Plasma, Serum, Urine, Saliva Industry Academia Government 6 Lung, Breast, Colon, Brain Bone Marrow, Blood, Tonsils, Lymph Nodes Applications Patients SUPPLY HEALTHCARE PROVIDERS DEMAND LIFE SCIENCE RESEARCHERS Biospecimens Data Organizations Medical Record
10 - 15% Annual Growth Fueled by precision and regenerative medicine research 2 Disconnected Market Participants in Need of a Marketplace Solution With an Inefficient Supply Chain Manual processes plus fragmentation make it ripe for an online marketplace solution Large and Inefficient Biospecimen Market $3 - $4 Billion Worldwide yearly spend on human biospecimen procurement 1 7 1, 2 “Sources Cited” page 28
Market Inefficiencies PROVIDER RESEARCHER Scientist / Informaticist Procurem ent Legal & Compliance IT / Informaticist Scientist & Informaticist Legal & Compliance IT / Informaticist Researcher & Procurement Legal & Compliance Principal Investigator & Specimen Operations PATIENTS PROVIDERS RESEARCHERS 8 Difficulties Connecting, Searching, and Compliantly Transacting 6 - 12 months on average to develop relationships, requiring the involvement of many stakeholders 3 3 “Sources Cited” page 28
Inefficiencies Lead to Losses Providers miss revenue and research opportunities > 3 Billion clinical specimens are discarded annually worldwide 5 > 1 Billion Patient encounters yearly in the U.S. where a specimen could be provided for research 4 > 800 Million banked specimens are in biorepository inventories worldwide 6 9 Researchers limit their work … in 2019, 82% of researchers limit the scope of their work due to shortage of quality biospecimens 8 “Challenging” and “Frustrating” most common words used to describe biospecimen procurement process by researchers 8 10 years ago, 81% of researchers said they limit the scope of their work due to difficulties obtaining biospecimens 7 4,5,6,7,8 “Sources Cited” page 28
The iSpecimen Marketplace Solution 10 PROVIDER Procurement Principal Investigator / Operations IT / Informaticist PATIENTS Legal & Compliance IT / Informaticist Researcher & Procurement Legal & Compliance Principal Investigator & Specimen Operations Scientist & Informaticist Blood / Pheresi s Centers Clinical Labs Biorepositories Pathology Labs RESEARCH PATHWAY CLINICAL PATHWAY Industry Academia Government RESEARCHERS An Online Platform That Instantly Connects Researchers to a Global Network of Patients, Biospecimens, and Data to Accelerate Time to Discovery Saves months in the average biospecimen procurement process PROVIDERS Healthcare Data
Full - Service Procurement We Not Only Connect Suppliers and Customers, but We Also Manage the Entire Procurement Process Click to See the Overview Video SPECIMEN SEARCH & SELECTION SPECIMEN LOGISTICS SPECIMEN MANAGEMENT DATA MANAGEMENT STUDY/ORDER MANAGEMENT SUPPLIER SITE TRAINING COLLECTION KIT BUILDING COMPLIANCE MANAGEMENT STUDY DESIGN & SPECIFICATION CONTRACTING 11 https://pages.ispecimen.com/rs/473 - GLR - 825/images/ISPCintro.mp4
Suppliers and Researchers Benefit Advance Discovery Suppor t research mission and advance diagnostic, therapeutic, and vaccine research Increase Revenue Instantly connect to a global network of researchers Ensure Compliance On a platform that protects the privacy and security of patient information Accelerate Research Search for specimens anytime, anywhere, through our easy - to - use online marketplace Save Money Instantly connect to a global network of specimen providers Reduce Risk On a platform that manages contracting and regulatory compliance Providers… Researchers… 12
13 34 66 102 147 181 197 2015 2016 2017 2018 2019 2020 September 30, 2021 Growing Supplier Adoption 1000+ Hospitals Also includes three Healthcare Information Exchanges 60% CAGR Number of Suppliers (2015 - Sept. 30, 2021) WORLDWIDE COVERAGE United States United Kingdom Germany France Ukraine Georgia Bulgaria Russian Federation India Peru Dominican Republic Jamaica Spain Cumulative Supplier Organizations Under Agreement 2015 – September 30, 2021 Unique Supplier Organizations Provide Access to: 000’s Clinics and Practice Groups ~55 Biorepositories ~140 Clinical Research Centers ~45 Clinical and Pathology Labs 6 Blood Centers 13
$700 $1,448 $3,067 $4,395 $4,298 $8,184 $8,586 2015 2016 2017 2018 2019 2020 September 30, 2021 Cumulative Customer Organizations with Purchases 2015 – September 30, 2021 63% CAGR Customers (2015 - Sept. 30, 2021) Revenue ($000) - Unaudited 2015 - 18 2015 – September 30, 2021 63% CAGR Revenue (2015 - Sept. 30, 2021) Growing Researcher Adoption 70% of the Top 20 Pharma Companies and 70% of the Top 20 IVD Companies Worldwide are iSpecimen customers are iSpecimen customers >160,000+ Specimens Across >2,100 Projects delivered to our customers 14 24 69 135 172 230 330 398 2015 2016 2017 2018 2019 2020 September 30, 2021
80 118 668 1,587 2,681 3,871 4,878 2015 2016 2017 2018 2019 2020 September 30, 2021 Cumulative Researcher and Supplier Marketplace Users 2015 – September 30, 2021 104% CAGR Registered Users (2015 - Sept. 30, 2020) Growing Marketplace Adoption ~3,300 Unique searches performed by researchers in the iSpecimen Marketplace in 2020 ~80% % of suppliers in the iSpecimen Marketplace with specimen requests in 2020 15 Annual Researcher and Supplier Marketplace Logins 2015 – September 30, 2021 53% CAGR Marketplace Logins (2015 - Sept. 30, 2021) 2,214 7,237 9,518 16,962 21,009 27,221 19,060 2015 2016 2017 2018 2019 2020 September 30, 2021
“Utilization of sample data for research and for monetization is the next key value driver for the biobanks.” - Frost & Sullivan, Global Biobanking Market Landscape Growing Data Asset Banked Specimen Records Patient Records Medical Condition Records Clinical Specimen Records Laboratory Test Records Millions of Unique Specimen and Patient Records provide a competitive advantage and differentiator now and available for future adjacent opportunities such as patient search, clinical trial recruitment, and data licensing. 72 M+ 16 1 M+ ~14 M 890K ~570 M
Statements of Operations (Unaudited) 17 $ 2.3 M $ 2.7 M 3M 9/30/20 3M 9/30/21 Revenue (3Q20 vs. 3Q21) 21 % $ 5.5 M $ 8.6 M 9M 9/30/20 9M 9/30/21 Revenue (YTD20 vs. YTD21 ) 57 %
Balance Sheet 18
19 Fully Diluted Shares of Common Stock Outstanding
Investor Summary 20 ~200 Healthcare Provider / Supplier Organizations ~400 Customer Organizations 1. Early - stage opportunity with a first mover advantage 2. $3B - $4B global biospecimen market growing at 10 - 15% per year 3. Unique two - sided marketplace disrupting the biospecimen procurement process 4. 90% year - over - year revenue growth (FY 2020 vs. FY 2019) and 57% year - over - year revenue growth (9 months 2021 vs. 9 months 2020) 5. Growing data asset that’s a key enabler and differentiator
CONNECT. INNOVATE. Sign up for free iSpecimen Marketplace account at www.ispecimen.com CONTACT US iSpecimen Inc. 450 Bedford Street Lexington, MA 02420 investors@ispecimen.com ispecimen.com
Appendix 22
Strategic Evolution PHASE 3 Expansion via the Online iSpecimen Marketplace Ƞ START UP Company Ideation and Self - Funding PHASE 1 Proof of Concept PHASE 2 Critical Mass of Suppliers and Early Customer Adoption 2010 – 2011 2012 – 2013 2014 – 2017 2018 – September 30, 2021 0 Customers 1 Supplier Agreement 0 Specimen Records 0 Patient Records 0 FTEs $500K Friends and Family Covert. Debt 1 Customer 3 Supplier Agreements 2+ Million Specimen Records 400+ Thousand Patient Records 7 FTEs $2.5M Series A 140+ Customers 60+ Supplier Agreement 26+ Million Specimen Records 5+ Million Patient Records 33 FTEs $8M Series B ~400 Customers ~200 Supplier Agreement ~73 Million Specimen Records ~14 Million Patient Records 52 FTEs $20M+ IPO 23
iSpecimen Marketplace UI/UX Use Pulldowns to Enter Three High Level Search Criteria Tissue Search Example 24
to View Initial Results View Case Cards to See Specimens that Meet Criteria 25 iSpecimen Marketplace UI/UX
Refine Search Results Using Sliders and Check Boxes Add Specimens to the Cart iSpecimen Marketplace UI/UX 26
View Cart and Add More Specimens Request a Quote iSpecimen Marketplace UI/UX 27 Track and Manage Requests
28 Page Note Source Cited 7 1 iSpecimen estimates based on In Vitro Diagnostics Market Size, Share & Trends Analysis Report By Product, By Application, By Technology (Immunochemistry, Molecular Diagnostics) By End - use, By Region, And Segment Forecasts, 2021 – 2027. Grandview Research, January 2021; and World Preview 2020,Outlook to 2026. EvaluatePharma, July 2020. 7 2 Global Marketing Insights, Precision Medicine Market Size By Technology (Big Data Analytics, Bioinformatics, Gene Sequencing, Drug Discovery, Companion Diagnostics), By Application (Oncology, Immunology, CNS, Respiratory), By End - use (Pharmaceutical Companies, Diagnostic Companies, Healthcare IT companies), Industry Analysis Report, Regional Outlook, Application Potential, Competitive Market Share & Forecast, 2020 - 2026, Feb. 2020. and Regenerative Medicine Market Size, Share and Industry Analysis by Product (Cell Therapy, Gene Therapy, Tissue Engineering, Platelet Rich Plasma), By Application (Orthopaedics, Wound Care, Oncology), By Distribution Channel (Hospitals, Clinics) & Re gio nal Forecast, 2019 – 2026. Fortune Business Insight, 2019. 8 3 Frost & Sullivan, Global Biobanking Market Landscape. May 20, 2020, page 357 . 9 4 Centers for Disease Control, https://www.cdc.gov/nchs/data/ahcd/namcs_summary/2016_namcs_web_tables.pdf 9 5 iSpecimen estimates based upon American Association of Clinical Chemistry US lab test data cited at https://www.360dx.com/research - funding/aacc - calls - congress - fund - clinical - lab - training - programs, 2020; and Clinical Lab Services, Global Market Trajectory and Analytics; Global Industry Analysts report, 2020. 9 6 iSpecimen estimate based upon Henderson, G.E., Cadigan, R.J., Edwards, T.P. et al. Characterizing biobank organizations in th e U .S.: results from a national survey, 2013; and Puchois, Comprehensive Biomarker Discovery and Validation for Clinical Application, 2013. 9 7 Holly A. Massett et al. Assessing the need for a standardized cancer HUman Biobank (caHUB): findings from a national survey w ith cancer researchers; JNCI Monographs, Volume 2011, Issue 42, June 2011. 9 8 Specimen Independent Researcher Survey, 2019. Sources Cited