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Claro Scientific LaboratoriesA Urine Drug Test that detects relapse sooner, faster, more often -
improving Rehab outcomes triggering a “Life Changing Conversation”
Drug Addiction Markets, Opportunity and ProductCurrent testing strategy – doesn’t catch cheatersDisruptive technology – changes how we testSurveillance tool measures treatment effectivenessBetter outcomes ↑ reimbursementColorado University Anschutz Medical School originsResume operations - commercial reference lab
Series A preferred - $500K Series B – $1 – 1.5M -
3-5 year exit - $50M revenue target
Drug Addiction
Crisis
• Fatal ODs > automobile, gun deaths• Top Google click phrase “Addiction
Recovery” • Mental health/addiction given Parity • Addiction recovery requires Drug Testing
• Easy to cheat current strategy• Claro – cost effective, true assessment of
ongoing drug use
• Success = Abstinence
Current methodology ‘sucks’
Antibody - Binding = signal• Relies on drug shape• Lots of shapes fit False Positive• High false negative result
• 29% opioids• 35% benzodiazapines• 43% amphetamines• 40% cocaine
• Confirm adds days & costs to results
This process will catch cheaters
Report 18 calibrators, 9 QCs, 100 samples32,000 data points
Urine barcoded Robotics 10X vs manual
Cloud based interface
=Sciex LC/MS/MS
Report
5
Immuno assays (IA) catch the big fish
But what about the little fish Claro has a fine
mesh net (LC/MS/MS)
We catch big and little fish with our advanced technology
Your bladder is a pond – what might be swimming around in it
Specimen adulteration- cut the net so even big fish get away
Can’t cut our net
Value proposition• Current testing is two phased and seriously flawed
• Screen (coarse net)• Clinician must confirm with LC/MS/MS• Adds $450 - $8500 bills and 3-7 days
• Claro – one rapid test for $250• Catch all fish at once (fine net)• Surveillance tool can optimize outcomes• Patients get better sooner• Better reimbursement
Catch all the fish
Claro Business Proposition
Large market
Hot space
Well vetted braintrust and
assets
High value service
proposition
Strong team and
plan
Multibillion dollar market, high profile
growing problem
Roots at CU Anschutz 4 year operating history
Delighted client base~$700K revenue
Market Validated
High science, client focused solutions
Excellent value
Deep operating, administrative and experienced leadership
Better faster actionable results lower cost, improved outcomesdrives VALUE
Competition’s business based on antiquated screen and confirm Hurdle to change strategy - throws away large segment of testing revenue
Test smarter,
less often,
yet deeper
• IA screening• 3X per week $380 - $960 month• Confirm big fish - more cost $$$
• ClaroLabs• Claro screen and confirm 2X a month = $500/month • Find all the fish at ½ price, faster cheaper
• COG • $5 fixed cost – labor, consumables, overhead• $10 - $20 for shipping or sample collection• Medicaid reimbursement - $250 • 10X margins
ClaroLabs has
already been
successful at CU
• Market validated ($700K/year)• Former customers waiting for restart• New guidelines favor ‘value based’ testing• Drug testing is part of treating drug addiction• Expanding market • Optimize treatment/outcomes• Improves reimbursement rates
Market potential -
$6.3B by 2019
• ~1% market share = $50M target• Market Segments
• Addiction recovery• Pain • Direct to consumer • Mandated Neonatal drug testing• DOT testing
• Timely introduction• Expanding epidemic • Outcomes based reimbursement model
Competitive
Landscape
National and Regional Reference Labs• Millennium - restructuring after $246M fine• Dominion – screen and pick panels• Ameritox - pain focus• Cordant – criminal justice focus
• Locked into screen and confirm, menu picks• Panels maximize revenue• Could mimic Claro approach• Competitors buy Claro package with royalty
Forecast
Year 1 Year 2 Year 3 Year 4 Year 5 Billings $ 1,600 $ 11,025 $ 20,700 $ 27,275 $ 34,650 Gross Receipts 275 9,975 19,550 25,025 34,650
Less: uncollectable (69) (2,494) (4,888) (6,256) (8,663)
Net Cash received 206 7,481 14,662 18,769 25,987
Expenses: COS & Equip Leasing 525 1,949 3,506 4,578 5,716 Sales & Marketing 81 443 736 1,012 1,364 SG&A 715 1,463 2,040 2,352 2,583
CAPEX 44 38 46 54 62 Total expenses 1,365 3,893 6,328 7,996 9,725
Net cash inc/(dec) (1,159) 3,588 8,334 10,773 16,262
Beginning Cash * 1,500 341 3,929 12,263 23,036
Ending Cash $ 341 $ 3,929 $ 12,263 $ 23,036 $ 39,298
* Assumes $1.5M Series A financing
Experienced Management Team
Layne Los, PhD – CEO - Serial entrepreneur, analytical, tech sales background
Lab creation at Bristol Myers Squibb, Merck, AAI, Cornell’s Equine Drug testing lab
Scott Kragerud, MS, CSO - Founder - Alpine Diagnostics – sets up turnkey UDT Lab
Sciex field application scientist, automation, UDT KOLJeff Dekker, CPA – CFO - Vice President of Finance, Controller at GlobeImmune
Financial projections/modelingJeffrey Galinkin, MD – Medical Director (Co-founder of Claro)
• Professor Analgesics and AddictionTerri Breitwieser – QA, billing and reimbursement expert
Consultant focused on Urine drug testing labs billing and regulatory complianceBaharak Davari –Lab Manager (original team)
Manages UDT lab in at AnschutzJacek Klepacki, PhD - Sr. Scientist (original team)
Method Development/validation scientist of the ClaroLabs assay
Phased restart - minimize risks, quick to revenue and profitability
Lab Lease, order
instruments
Lab setup equipment
method validation
CLIA Certificati
on Revenue
generating samples
Scaling Operation (second funding round if needed)
Intensive S&M
Activity
Profitability
R&DNew
services/technology
Acquisition 2 - 4X revenue
FundingSeries A$500K or$2.0M
0 3 6 9 12 18 24 36- 60
Schedule first customers
Add new technology and services
Drugs of Abuse and Clinical Lab AcquisitionsAcquiror Acqiree Revenue
(millions)Price
(millions)Rev.
Mltpl.Date
LabCorp Covance $2,600 $5,600 2.2 2015LabCorp Sequenom $128 $302 2.4 2015LabCorp LipoScience $52 $85 1.6 2014Quest Diagnostics Solstas Lab Partners $450 $572 1.3 2014Alere eScreen $120 $340 2.8 2012LabCorp Genzyme Genetics $371 $925 2.5 2010LabCorp Monogram Bioscience $64 $107 1.7 2009Inverness Med. Innov. Concateno $76 $106 1.4 2009Quest Diagnostics Lab One $300 $934 3.1 2005
Very few reasonably sized acquisitions with enough information to be relevant. Too many small, sometimes family run companies changing hands rather than go bankrupt.
Pieces queued up for a restart
• A need for our test• Product durability, reliability, sensitivity and
value • Demonstrated market uptake• Lab Space - Class A• Basic Lab equipment purchased • Scientists with exact experience committed• Incentivized ‘Rock Star’ management team • Clear path to revenue and profitability
Phase I
• Seed funding of $500K – Where that gets us• CLIA accreditation• Revenue generating assay• Sweat equity from Sr. Staff
• Use of funds • Lab Supervisor, IT and office support salaries• Lab and Office space • Instrument lease for LC/MS/MS (likely Sciex) • Colorado Sales support
• Functioning business
17
Phase II redundan
cy capacity
automation
expertise ($1-1.5M)
Scale operationUse of funds
• Second and third Instrument• CAP certification• Add staff • Bar coding• Billing and sample management automation• Expand Sales efforts • Cash flow
• Profitable business
18
Terms for New
Financing
• $500,00 in Series A Preferred in Claro Scientific Laboratories, a Delaware C corporation
• Board composed of CEO, two Series A investors, and two outsiders approved by other board members
• $1.72 per share, new investors will hold 12.5% of Claro after financing
• Other standard Series A preferred terms as the most senior and only preferred security
The Ask
Series A preferred with $4M Valuation$500K = 12.5 % equity
Series B – $6M valuation$1.5M = 25 % Equity
Growth to $50M revenue in 3-5 years$100M- $200M acquisition
Series A preferred $100K = $2.5 - $5MSeries B $150K = $2.5 - $5M
Capitalization TablePre-Close New Mgmt Post SeriesCommon Options A Closing
Current LLC ownership
46% Founder 461,659 46% 461,659 23% 461,659 20%26% CU Doctor #1 258,642 26% 258,642 13% 258,642 11%11% Outside Investor 107,720 11% 107,720 5% 107,720 5%9% CU Doctor #2 91,581 9% 91,581 5% 91,581 4%2% CU 20,343 2% 20,343 1% 50,580 2% note 16% Options 60,053 6% 60,053 3% 60,053 3%
100% 999,998 999,998 1,030,235
600,000 LL 30% 600,000 26%400,000 ISO 20% 400,000 17%
1,999,998 2,030,235
$500,000 $1.72 per share Series A preferred 291,265 12.5% $500,000 $1.72TOTAL 2,321,500 100% $3,485,207.40 Pre-Money
note 1: MUST BE HELD AT 2% due to CU - TTO license up to $2M
Drug Addiction Crisis
Drug ODs > car & gun deathsOld strategy flawedRecovery requires abstinenceSurveillance tool Optimize clinical outcomes ↑ reimbursement rates
Claro is
Market validatedMost advancedEfficientCost effectiveBest Value
Phase I – $500KCLIA certificationRevenue generating
Phase II – 1.5MRedundancyScale operationSales ramp up
Current methodology SucksOnly big fish
=
Efficient High tech answer
Back pocket slides
ClaroLabs provides a surveillance tool• With the advent of the National Outcome Measures that each state is now
required to report to the federal government as part of the block grant process, independent verification of a client's use at intake, improvements during treatment and abstinence at discharge is highly valuable. This will allow treatment programs to demonstrate their effectiveness and be in a better position to advocate continued or increased funding.*
• ClaroLab’s surveillance tool can truly measure abstinence the marker for addict success, individual counselors and clinics effectiveness.
• ClaroLabs will provide feedback on what training and approaches improve client abstinence rates which increases reimbursement.
• ClaroLabs data feeds a treatment optimization platform – secondary business*Drug Testing White Paper Amer. Soc. Addic. 10/26/2013 Med.
26
Expansion – surrounding states, nation wide royalty play, new services and technology
• Clinical Chemistry/Genomics –
• Multi State expansion into CA, UT, NM, AZ, NV
• Direct to consumer – Walgreen, Walmart, our website ($189 kit)
• Saliva and hair testing for specific niches
• DOT testing – poorly served, low quality, higher pricing
• License the assay (510K?) to go national (Patentable IP)
• MMJ testing for pesticides, fungicides, mildewcides
• Drug Metabolism – Met-ID and production
Claro Corporate History• The company was founded in 2010 to pursue banned substance testing for the sports industry in
a contracted collaboration with the CU School of Medicine• After spending 18 months developing a broad based, 100+ drug, multiplexing assay for drug
testing, Claro refocused the testing services on the larger market of Urine Drug testing for the medical and recovery industry
• During 2012-2014 CU spent over $1.5M on equipment and hired a staff of five dedicated employees to address growing demand to support the collaboration
• Claro has invested over $1.5m in the development of software to support analytical analysis, reporting and customer management
• As the customer base grew, is was recognized that additional capital would be required to grow the business. CU would not support outside investors being involved; in 2015 the collaboration was terminated. Claro holds the rights to the trade secret analytical methods and owns the software used for analytical analysis, sample reporting and customer management.
Role for Founder prior employees• Existing investors committed to $125K of the $500k Financing• Founder available to be on Board• Many of the the employees of the CU laboratory are available and
interested in joining Claro