NuSep Investor Presentation
Transcript of NuSep Investor Presentation
NuSep Holdings Ltd 30 Richmond Rd
Homebush NSW 2140
Postal Address P.O. Box 2202
Homebush West NSW 2140
Contact Details
Telephone +61 2 8415 7300
Facsimile +61 2 8415 7399
Email [email protected]
Web www.nusep.com
ABN 33 120 047 556
FOR IMMEDIATE RELEASE
NuSep Investor Presentation
Sydney, Australia 10th July 2013– NuSep (ASX:NSP). Attached is the latest investor presentation by the Company. **ENDS** For more information please contact: Contact: Prakash Patel Managing Director +61 2 8415 7300 About NuSep NuSep (ASX: NSP) is a publicly listed life sciences company that sells products into the global BioSeparations market. The company has offices in both Sydney Australia and Atlanta, USA. With a 30 year heritage in biological separations, NuSep has forged a world class reputation for its innovative yet simple biological separation techniques based on its PrIME1 technology. The PrIME technology has produced a number of world firsts including the world’s first IVF sperm separation device. In short NuSep has redefined the BioSeparations market through innovation and simplification. NuSep’s world renowned research team has developed an extensive portfolio of patented products. In all, NuSep currently manufactures, distributes and sells 55 products to customers in the USA, Europe, Asia and Australia. NuSep Products:
Gels – NuSep manufactures and sells precast gels including the innovative nUView Gels, which can be visualised 2 minutes after use.
Separation Instruments – NuSep has developed two unique biological separation instruments. The ProteomeSep can separate biological samples into 8 fractions for use in the proteomic market. The SpermSep separates sperm for fertility treatments such as IVF.
Biological Products – NuSep supplies research grade biological products manufactured using its unique separation technologies. These products include human IgG and Albumin.
1 PrIME stands for Preparative Isolation by Membrane Electrophoresis
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For more information about NuSep please visit the company’s website www.NuSep.com About PrIME Biologics Pte Ltd PrIME Biologics is a Singapore based biotech company that has developed a disposable therapeutic plasma manufacturing process based on NuSep’s PrIME Technology. NuSep has a 90% shareholding in PrIME Biologics. PrIME Biologics process is based on the Preparative Isolation by Membrane Electrophoresis (PrIME) technology developed by NuSep. PrIME provides disposable modular processing that is ‘electronically’ driven membrane fractionation. The PrIME process increases product yields to over 90% relative to the existing process 50% while increasing product safety. The PrIME has been shown to remove virus, bacteria, endotoxins and prions which cause ‘Mad Cow Disease’. Further, PrIME Biologics process can produce multiple plasma products in hours compared to days, which is required by the current manufacturers. The initial application for the PrIME process will be the Currently Unprocessable Plasma which represents approximately 50% of all the plasma collected in many Asian countries.
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DISCLAIMER
This presentation is not and does not form part of any offer, invitation or recommendation in respect of securities. Any decision to buy or sell NuSep securities or other products should be made only after seeking appropriate financial advice. Reliance should not be placed on information or opinions contained in this presentation and subject only to any legal obligation to do so, the Company does not accept any obligation to correct or update them. This presentation does not take into consideration the investment objectives, financial situation or particular needs of any particular investor.
To the fullest extent permitted by law, NuSep and its affiliates and their respective officers, directors, employees and agents, accept no responsibility for any information provided in this presentation, including any forward looking information, and disclaim and liability whatsoever (including for negligence) for any loss howsoever arising from any use of this presentation or reliance on anything contained in or omitted from it or otherwise arising in connection with this.
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The PrIME Opportunity
The Problem
•Acute Shortage of Asian Emergency Plasma Drugs; and
•The Raw Material (plasma) is currently Discarded.
The Solution
PrIME opens $2b Asian market by processing waste plasma using unique PrIME Technology
Investment Return
•Create multi billion Company;
•Investment of $15m;
•NPV $84m @20% discount & IRR of 38%.
PrIME stands for Preparative Isolation by Membrane Electrophoresis
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PrIME Business Model
$2BMay 2013
Acute Shortage of AsianEmergency Plasma Drugs
SingaporecGMP
Manufacturing Facility
Fractionation(PrIME)
TechnologyWas
tePl
asm
a
Clin
ical
Tr
ial
24 Months
Waste Plasma
Over 50% of all Plasma Collected in Asia is thrown away.
Singapore Facility
•cGMP facility;•Pilot PrIME installed;•3 batches of cGMP Albumin.
PrIME Technology
•Unique technology;•Opens up the untapped Asian Market.
Clinical Trial
•40 Patient, 12 months trial;•10 patients already identified.
$2B
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5 Steps to First Sales
cGMPApproval
Recommission Facility
Lodge application
Audit by HSAApproval post
audit
Manufacture Clinical Products
Make 3 batches of each product
Put product aside for stability testing
Start Clinical Trial
CRO will run the clinical trials
Follow patients for 12 months
Collect and analyse data
Apply for Registration
Submit data to HSA for registration
Product Registration
First sales will occur on Product Registration by HSA
Registration & First Sales in $2B Market
cGMP Facility Approval
Manufacture Clinical Product
Start Clinical Trials
Finish Trials/Apply for Registration
Dec 2013 March 2014 April 2014 April 2015 Dec 2015
CUPJUNE 2014
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5 Steps Process
cGMPApproval
Manufacture Clinical Products
Start Clinical Trial
Apply for Registration
Product Registration
Start up EquipmentWrite up processesLodge applicationUndertake audit
Make 3 production batchesQC batchesShip to Clinical trail sitesStart stability testing
Truncated clinical trail40 patients over 12 monthsEndpoint, same as existing products
Write up trial resultsSubmit to HSARespond to HSA questionsReceive HSA approval
PrIME Value(at each of the 5 Steps)
cGMP Approval
Manufacture Clinical Product
Start Clinical Trial
Apply for Registration
2015 P/E Market ValueRisk Weighting
(value as % of 2015 Market Value)25% 40% 70% 90%
Base Case $110m $190m $330m $420m $460m
Contract Case $230m $370m $650m $840m $930m
Optimistic Case $310m $500m $880m $1,130m $1,250mFor
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AsianPlasma Disposable
Process
• Processing the ‘Waste’ or Currently Unprocessable Plasma (CUP) allows self sufficiency for regional areas.
Low Cost Therapeutic Products
• To Process CUP requires a disposable production method - NuSep’s patented PrIME process is such a process.
Market Entry Strategy – CUP Market
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Market Entry Model and Order book
Order Book – Yearly
Singapore: 10,000 LitresIndia: 50,000 Litres
Revenue: S$32M (A$25M)
Plasma is drawn from India, Processed in Singapore and sold back to India as an Active Ingredient
Model
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PrIME Biologics Budget
Budget in S$Calendar years
2013S$M
2014S$M
2015S$M
2016S$M
PrIME% to Sales
Cohn % to Sales
PrIME∆to Cohn
Sales $- $- $33.5 $62
Gross Profit ($0.6) $0.4 $26.5 $50.5 81% ~50% +62%
EBITDA ($4.2) ($4.7) $22.9 $46.3 74% ~40% +85%
NPAT ($4.3) ($5.2) $20.2 $37.9 60% ~35% +71%
NPV on the PrIME Biologics Project using a 20% Discount is S$84mIRR on the PrIME Biologics Project is 38%
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PrIME Sustainable Competitive Advantage
The PrIME1 Technology addresses the acute shortage of emergency plasma drugs in Asia by processing the wasted
plasma and producing a safer, cheaper locally manufactured product. PrIME achieves this by:
•Processing the Wasted PlasmaPlasma represents 45% of the cost of the current therapeutic products;
•High Product Yield, Small batch size & Short production runs PrIME produces twice the end product in less time and smaller batches from a Litre of plasma than the current processes;
•Added Product SafetyPrIME removes viruses and Prions other systems can’t;
•Low Capital CostPrIME is a low capital cost process.
1 PrIME is Preparative Isolation by Membrane Electrophoresis
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The PrIME Technology
PrIME is a platform technology and NuSep is developing the following applications:
•Current ApplicationTherapeutic Plasma Fractionation - ($10b);
•Applications Under DevelopmentSperm Separation – (100m);Dengue Diagnostic & Therapy – ($1b)
•Future Applications could includeDialysis – ($19b);Recombinant Separations – ($60b);Toxin Removal.
Each new application creates a new annuity sales stream for NuSep.
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PrIME Technology Applications
PrIME Fractionation $10B
60B
Sub 1B
Time to Market
Market Size
IVF $100m Market
20B
10B
2014 2015 2016 2017 2018
Renal Dialysis $19B
Recombinant Therapeutics $60B
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3 Step Business Model
1. Develop applications of the PrIME Technology to better address existing markets
2. Spin out new applications as separate companies bring in new investors to fund and give NuSep shareholders in species distribution
3. Each application generates a new annuity sales stream for NuSep
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PrIME Achievements
• Grant from Singapore Government.
• ABS agreement to fractionate CUP.
• Acquisition of Singapore cGMP facility.
• Transfer of Pilot Scale PrIME unit to Singapore.
• Appointment of key regulatory personnel.
• Decision to Spin Out PrIME.
• Future PrIME funding pending.
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Dollar Value Comparison of Existing Cohn Process vs PrIME
Plasma Product
Plasma Con1
g/L
Value per g protein
Cohn2
Yield g/L
Cohn % Yield
Cohn $/L PrIME3Yield g/L
PrIME % Yield
PrIME $/L Δ g/L Cohn to PrIME4
100,000L pa Δ Cohn & PrIMEKg $M5
Albumin 40g $2.50 25g 65% $62.5 34g 85% $85.0 9g/L 0.9kg $2.25m
IVIG 10g $50.00 4g 40% $200 8g 80% $400 4g/L 0.4kg $20m
Total $52.50 29g $262.50 42g $485.00 13g/L 1.3kg $22.25m
KEY1.This is the normal concentration of these proteins in a litre of Human Plasma.2.Cohn fractionation is the technology used by the existing fractionators.3.PrIME is the disposable manufacturing process used by PrIME Biologics.4.This column shows the additional protein per gram manufactured using the PrIME process.5.This column shows the additional profit gained by using the PrIME over the Cohn process.F
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