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MEMPHASYS LIMITED. — AGM Information 2013
Nov 28, 2013
65314_rns_2013-11-28_1e3a5017-05d8-49af-9130-3047fe81c113.pdf
AGM Information
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NuSep AGM Presentation November 2013
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DISCLAIMER
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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.
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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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NuSep
Chairman’s Address
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The PrIME Technology
The PrIME Technology is a platform technology and NuSep is developing the following applications:
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Each application generates: Equipment; and Consumables sales . for NuSep
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PrIME Technology Applications
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60B
Recombinant Therapeutics $60b
Market
Size
20B
Renal Dialysis $20b
10B
PrIME Fractionation $10b
Sub 1B
IVF $100m Market
2014 2015 2016 2017 2018
Time to Market
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NuSep Holdings 3 Step Business Model
1. Develop applications of the PrIME Technology.
2. Spin out new applications to: Fund commercialisation; Generate funds for NuSep; and Provide an in specie distribution to NuSep Shareholders
3. Each application also generates: Equipment; and Consumable membrane sales for NuSep
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The PrIME Opportunity
The Problem
The Solution
Investment Return
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Acute Shortage of Asian Emergency Plasma Drugs; and
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The Raw Material (plasma) is currently Discarded.
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PrIME opens $2b Asian Create multi billion market by processing Company; waste plasma using •
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unique PrIME Investment of $15m; Technology
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Investment of $15m;
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NPV $84m @20% discount & IRR of 38%.
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PrIME stands for Pr eparative I solation by M embrane E lectrophoresis
5 Steps Process
cGMP Manufacture Approval Clinical Products
Start Clinical Trial
Apply for Product Registration Registration
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Start up � Make 3 production � Truncated clinical � Write up trial results
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Equipment batches trail � Submit to HSA
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� Write up � QC batches � 40 patients over 12 � Respond to HSA
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processes � Ship to Clinical trail months questions
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� Lodge application sites � Endpoint, same as � Receive HSA approval
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� Undertake audit � Start stability testing existing products
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- ASX P/E for the Biotech Sector 1 August 2013 was 16.1
Market Entry Strategy – CUP Market Advantage
- Processing the ‘Waste’ or Currently Unprocessable Plasma (CUP) allows self sufficiency for regional areas.
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Asian
Disposable
Plasma Low Cost
Process Therapeutic
Products
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- To Process CUP requires a disposable production method - NuSep’s patented PrIME process is such a process.
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- 1 PrIME is Pr eparative I solation by M embrane E lectrophoresis
Dollar Value Comparison of Existin Cohn Process vs PrIME g
| Plasma Product |
Plasma Con1 g/L |
Value per g protein |
Cohn2 Yield g/L |
Cohn % Yield |
Cohn $/L | PrIME3 Yield g/L |
PrIME % Yield |
PrIME $/L | Δ g/L Cohn to PrIME4 |
100,000L pa Δ Cohn & PrIME Kg $M5 |
100,000L pa Δ Cohn & PrIME Kg $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 |
KEY
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This is the normal concentration of these proteins in a litre of Human Plasma.
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Cohn fractionation is the technology used by the existing fractionators.
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PrIME is the disposable manufacturing process used by PrIME Biologics.
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This column shows the additional protein per gram manufactured using the PrIME process.
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This column shows the additional profit gained by using the PrIME over the Cohn process.
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PrIME GF100 in situ at PrIME’s Singapore Fractionation Facility
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The NuSep PrIME Structure
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NuSep is the ASX NuSep NuSep has ~950
Listed Parent shareholders
Holdings Ltd
Company
PrIME Biologics
PrIME Biologics is a
is a subsidiary of
Singapore private
PrIME Biologics
NuSep
Company
Pte Ltd
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PrIME Biologics Funding
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29 October 2013 announced S$15m non-binding Term Sheet for PrIME Biologics from Xeraya Capital.
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Demerger of PrIME Biologics from NuSep is a precondition of Xeraya Capital funding. Expect to hold an EGM to approve the demerger in February/March 2014.
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• NuSep shareholders will receive at least 50% of PrIME Biologics, subject to final valuation.
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PrIME Biologics Shareholding
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expected
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NuSep Board Refresh
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Appointment of Alison Coutts
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John Manusu, Dr Hari Nair & Clifford Eu to step down from the NuSep Board
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Additional Board appointments post AGM
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John Manusu & Dr Hari Nair remain on the PrIME Biologics Board to manage PrIME Biologics
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NuSep
Managing Director’s Address
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NuSep
NuSep’s greatest asset is the PrIME Technology and its associated Intellectual Property (IP). It is worth noting that the PrIME Biologics therapeutic plasma application is just the first, and not even the largest, application of PrIME Technology.
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NuSep- PrIME Technology ~~Annual Revenue Streams~~
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Equipment Membrane
Royalty
Sales Sales
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NuSep- PrIME Technology ~~Annual Revenue Streams~~
Royalty to NuSep from each PrIME sites
NuSep
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NuSep Equipment Sales to each PrIME site in addition to NuSep Membrane Sales of ~$4m-$5m per PrIME site/ per year
NuSep- PrIME Technology Annual Revenue Streams
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PrIME
Biologics-
PrIME
Singapore
Biologics
– India
PrIME
Biologics
– Asia
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NuSep Revenue $$$ Equipment; Membrane; Royalty
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NuSep Financials 2012/13
• Full year results to 30 June 2013;
- Total Income
$1,468,857
- Net Loss
$1,841,920
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This is a $7+M turn around on the $9m loss for the financial year ended 30 June 2012 and represents a 81% improvement relative to the previous year.
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Total Equity increased by $5,607,499 or 406% to $6,990,106 for the year to 30 June 2013.
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NuSep 2012/13
• The Financial year also saw;
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The acquisition of the Fractionation Plant in Singapore
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The successful completion of three trial production runs of Human Albumin using its
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Pilot production unit in this cGMP production facility in Singapore
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The move to the new facility in Homebush, Sydney
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S$15m non-binding term sheet for PrIME Biologics from Xeraya Capital
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$1.6m Australia R&D tax refund funding
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NuSep Consumables
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Continued focus on key high margin Gels markets - US and Europe
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International Sales & Marketing push by OEM Distributor Thermo Fisher during the year
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NuSep has established additional International Distributor Channels
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Focus on Distributor Sales through strong partnership, training and support
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“ ”
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� Launch of our Kaogen branded in-vitro Diagnostics product range during the in of EU of year, currently process completing regulatory registration
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these in-vitro diagnostics products. Expect EU sales in early 2014.
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NuSep is one of the first IVD manufacturers in Australia to have achieved TGA accreditation under the recently introduced requirement for ISO 13485 compliance.
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NuSep Membrane
� NuSep Membrane is the heart of the PrIME Technology
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Every new application of PrIME will require a perpetual ongoing supply of the consumable membranes. Thus each new becomes a new application
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annuity income stream for NuSep.
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NuSep has intellectual property covering the membrane manufacturing and the Additional intellectual
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process disposable cartridge concept. property will be created to protect each application.
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� Ultimately, it will be the consumable membrane income stream that will create the most value for NuSep. In time NuSep will become a consumable membranes company.
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NuSep Membrane Manufacturing
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Successfull Membrane production batches completed at new Homebush facility
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In 2013, NuSep lodged patents for improved Membrane manufacturing which is to increase Membrane
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processes expected significantly production output volume and reduce manufacturing costs
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NuSep has sufficient production capacity to supply PrIME Biologics Membrane purchase requirements for 2014, additional production capacity will be added during 2014 to meet future purchase demand
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NuSep achieved Therapeutic Goods Administration (TGA) accreditation for in 2012. This certification is as we are
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Diagnostics assisting NuSep preparing the membrane manufacturing process to supply PrIME Biologics with cartridges to manufacture Therapeutic plasma products and SpermSep with IVF cartridges.
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SpermSep
• Second PrIME Application - Isolation of Healthy Sperm for IVF – SpermSep
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The Problem
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Low success rate using the exiting process; and
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Potential for sample confusion.
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The Solution
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Separate the sperm using a single use disposable
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PrIME Technology cartridge.
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Investment Return
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Create a company focused on supplying the IVF market; and
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Investment under $10m;
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SpermSep
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SpermSep - Steps to Market
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Final sale ready instrument and membranes
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Final Clinical study (6-9months)
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Regulatory registration
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We expect first sales in 2014/15 year
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Dengue Diagnostic & Therapeutic
• New Application of PrIME: Dengue Diagnostic & Therapeutic
In May 2013, NuSep lodged patents for both the development of a diagnostic and a therapeutic for the treatment of dengue haemorrhagic fever based on the PrIME Technology. NuSep has selected Dengue as an application of the PrIME Technology as it best met the criteria outlined by the Company, specifically:
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The existing Dengue diagnostics and treatment do not meet the current market needs;
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Dengue represents a large and growing market; and
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The PrIME Technology offers a faster, more accurate and effective alternative.
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NuSep Holdings New Head Office
• 30 Richmond St Homebush West NSW 2140
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www.NuSep.com
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