PIQ Overview as of July 2020.

The following was taken from STARMAN member 'CanadianAussie'.
It is an extremely well researched and excellent summary of PIQ in its current state.
I hope new investors find it useful in their analysis and research & if you're out there Canadian Aussie, - thank you for putting this together! .

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Thesis

•Passionate, talented, founder led company

•Founder/CEO has a reasonable salary and ~22% ownership with recent insider buying on market indicating aligned management

•Board members Paul House and Ian Roger Moore have also recently purchased shares on market

•Talented and experienced senior management team (4 PhDs) and BOD with proven track records

•Founder uses terms like “we” vs “I” when discussing company

•IP and patents filed in Europe, Japan, Australia, Russia, Singapore, Indonesia, China & USA*. Were the first proteomics lab (2009) to be recognised and accredited worldwide.

•Possess a competitive advantage – PromarkerD test - currently no other test for predicting a patient’s risk of developing diabetic kidney disease. Commercialised, low-cost, high-speed test.

•Potential for further moats with pipeline of R&D – for example detection of endometriosis via blood sample as opposed to laparoscopy (minor surgery), among others.

•Potential to serve customers globally (working on expanding into US), operates in a stable market, serves/potential to serve multiple industries (healthcare, biopharma, agricultural, elite sport health and animal health)*. For example, they test proteins for A2 Milk.

•Possess economies of scale

•Have large addressable markets, short clinical development time for new products (24 to 27 months) and proprietary platform technology

•Has several projects in pipeline, 4 of which are roughly 1 year from commercialisation

•Little coverage (unknown)

•Tailwinds – rates of diabetes are increasing – one of the world’s fastest growing diseases. Growing biosimilars market further fuelled as existing drugs come off patent.

•Free cash flow positive

•Debt free with a current ratio >7

•Scalable with high margins - employ an out-licensing model for their current & future diagnostic tests allowing them to leverage sales and marketing of their distribution partners

•Analytical services revenue ($1.5M FY19) helps offset R&D and product development expenditure – not your typical biotech nor does it have a binary outcome (ie. success or complete failure)

•World leading facility in Western Australia (recently upgraded) with a $4m co-investment from Federal and State Government agencies

*R&D pipeline (not yet proven) exploring diagnostic tests for endometriosis, giardia, asthma & COPD, plant dieback, diabetic retinopathy, oxidative stress (human & animal applications), cancer, COVID-19

Summary

PIQ has asymmetrical payoff atypical of your standard biotech company. Revenue from their analytics division de-risks and lowers the downside by funding the R&D arm of the company. They are currently free cash flow positive as a result. PIQ has patents approved and pending (including the US) which provide them with a strong competitive advantage until 2031 in a highly competitive sector. Regulatory (need to reduce healthcare costs) and societal (increasing rate of diabetes) provide tailwinds that will benefit the company.

They have a passionate, founder led management team with plenty of talent; however, management have missed some significant milestones – most notably in the commercialisation of their PromarkerD product in the US and this is where my biggest concern lies. However, recent management buying on market eases this concern.

For a biotech company lacking your typical binary outcome, PIQ may be best suited as a bottom drawer or coffee can stock as the payoff could still be some time away.

Would Sell If

The company’s current focus is to commercialise PromarkerD test in major markets such as the US, develop more diagnostic testing and grow its analytical services revenue.

Therefore, I would sell if:

•Management fails to execute into the US market

•R&D pipeline (diagnostic testing) has multiple failures, limiting their growth into additional markets

•Analytical services revenue declines or flat lines for a significant period or is unable to continue to fund PIQs R&D

About

Proteomics International (PIQ) is a medical technology company operating in the predictive diagnostics and bio-analytical services. PIQ aims to use proteomics to develop and commercialise diagnostic tests for chronic diseases.

Proteomics is the large-scale mapping of the structure and function of proteins. Genes are static, the genes we are born with are the genes we die with, but the protein make-up of our bodies differs from cell to cell and changes over time (as we age or if we’re sick). As an example, a cancerous cell will have significantly different proteins to a healthy cell. While a caterpillar and a butterfly will have the same genes their proteins will differ.

It is this difference in proteins that PIQ is exploiting with their diagnostic tests to detect diseases such as chronic kidney disease (CKD) in diabetics.

Proteomics International uses its proteomics-based tech platform in diagnostics, analytical services and therapeutic drug discovery with their current focus to commercialise their PromarkerD test for chronic kidney disease (CKD) in major markets.

PIQs strategy is to:

Commercialise its test for diabetic kidney disease – PromarkerD - in which it will receive licensing fees and royalty payments.

Research and develop other diagnostic tests (see R&D Pipeline write-up) – as these tests are commercialised they will boost revenue through licensing fees and royalty payments.

Provide analytical services on a fee-for-service. This not only offers synergies in access to markets and clients but helps offset R&D and product development expenditure. PIQs analytical services serve the needs of pharmaceutical, biotechnology and life science companies and academic institutions across the world.

Products and Services

PromarkerD Test System

Blood test assessing the risk of diabetic kidney disease (DKD) in diabetic patients.

Simple blood test measuring a panel of three novel protein biomarkers (“fingerprints”) combined with three clinical factors.

The combined data is submitted to the PromarkerD Hub and a test report is generated. PromarkerD Hub is a software tool that contains a proprietary algorithm to calculate the risk of DKD.

The ability of the biomarkers to diagnose and predict diabetic kidney disease has been studied and verified. In validated clinical studies, the PromarkerD test system predicted 86% of otherwise healthy diabetics who went on to develop DKD within four years.

Promarker™ Platform

The Promarker™ platform uses mass spectrometry-based technology to identify the proteins that can be used as biological markers of disease and other conditions.

PromarkerD’s ability to predict and diagnose diabetic kidney disease in patients was verified by the Promarker™ platform and studied in three clinical studies:

The Prognostic Validation Study

In this validation study, PromarkerD correctly predicted 86% of previously disease-free patients who went on to develop chronic kidney disease.

The Prognostic Development Study

In this development study, PromarkerD correctly predicted 95% of otherwise healthy diabetics who go on to develop chronic kidney disease within four years. (ADA Poster 2017 & JDC 2019)

The Diagnostic Study

The study showed that PromarkerD outperformed both the current gold standard tests used for the diagnosis of patients already suffering from DKD.

The Company has developed two types of tests to capture mass market:

PromarkerD test for diabetic kidney disease is available in two technology platforms (mass spectrometry and immunoassay – also known as in vitro diagnostic IVD), servicing the Laboratory Developed Test (LDT) and IVD markets. This means it can be manufactured as either a kit or configured to run on automated immunoassay platforms to meet the diverse needs of clinical diagnostics laboratories.

LDT - Certified laboratories can carry out PromarkerD analysis using an LDT. In an LDT, specialised laboratories use mass spectrometers to measure the protein fingerprint in the patient’s blood. The data is then sent to the PromarkerD hub for processing and diagnosis.

IVD - Pathology laboratories can carry out PromarkerD analysis using an IVD. In an IVD, laboratories use traditional immunoassay technology, standard to all pathology laboratories, to measure the protein fingerprint. The data is then sent to the PromarkerD hub for processing and diagnosis.

PIQs Analytical Services - serving two main areas:

Pharmacokinetics – study of what happens to a drug when it enters the body, whereas pharmacodynamics and companion diagnostics profile patient response to treatment by measuring markers in the blood. Together they may help doctors develop personalised treatments.

Pharmacokinetic testing is crucial in the development and commercialisation of new drugs. It helps to ensure drugs are safe and effective as well as examining how the drug changes in individual patients.

CDx - When a diagnostic test is used alongside a drug therapy, it is known as a companion or complementary diagnostic (CDx). PromarkerD can act as a companion diagnostic test to help identify patients for whom a drug will or will not work, reducing drug failure rates in clinical trials and improving patient outcomes.

CDx provides PIQ with another way to serve the biopharmaceutical industry or drug development industry.

Biosimilars – are essentially generic versions of drugs. As drugs come off patent they can be copied with biosimilars and marketed.

PIQ can undertake pre-clinical and clinical pharmacokinetic quantitative assays for any investigational drug product.

Cutting-edge protein biomarker analysis facility in Western Australia

The facility will provide increased ability to explore for and identify biological markers across a broad range of sectors. This could lead to the identification of new drug targets and the creation of diagnostic tests across medicine and agriculture, boosting both Proteomics International's analytical services and R&D activities.

Addressable Market

The Problem

Diabetic kidney disease (DKD) is kidney damage caused by diabetes.

The role of your kidneys is to filter waste and excess water from the blood making urine.

High blood glucose levels characteristic of diabetes can progressively damage blood vessels in the kidneys, reducing their ability to filter out waste.

Rates of diabetes are fuelled by obesity, poor diet and inactivity, increasing the fastest in low and middle-income countries.

DKD costs $100k per person per year and if left untreated the patient is at a high risk of kidney failure. The only treatment options for kidney failure are either dialysis or kidney transplant.

More than 500M people have diabetes (1 in 11 adults) with 1 in 3 of these having DKD.

Current tests can only detect the disease by measuring existing kidney damage and cannot predict the risk of developing DKD. 9 out of 10 patients with kidney damage are asymptomatic and live unaware.

The current gold standard tests for diagnosing DKD are:

• a urine test
• a blood test

The shortfalls of the current gold standard tests are:

• Can only detect diabetic kidney disease when there has already been damage
• Current tests not always reliable

PromarkerD test system is the first test globally capable of predicting the onset of DKD before clinical symptoms appear and has been validated in clinical studies - predicting 86% of otherwise healthy diabetics who went on to develop chronic kidney disease within four years.

PromarkerD test allows the patient to implement preventative measures (diet, lifestyle, and blood pressure drugs) before kidney damage occurs leading to better health outcomes and simplifying patient care.

PromarkerD enables a more comprehensive assessment and informed approach to help:

• Identify patients at risk of developing DKD within the next four years
• Implement preventative measures before kidney damage occurs
• Personalise patient treatment plans
• Improve patient monitoring and management

Early detection can significantly help prevent serious kidney damage

The global clinical trials market is projected to reach $22 billion by 2021

Biosimilars Testing Market

Majority of the top 10 selling drugs on the planet are protein-based drugs and it is the generic copies of these drugs, the biosimilars that PIQ is hoping to take advantage of.

PIQ plans to serve the drug development market through its high-end facility in Western Australia.

The global biosimilars market size is expected to reach a value of USD$61.47 billion by 2025 and to expand at a 34.2% CAGR over this period. Several of the existing biological drugs will be reaching patent expiry in the coming decade, which would provide an opportunity for many innovator companies as well as generic manufacturers to offer services, specially tailored toward biosimilars.

Pharmacokinetic Testing Market:

The global pharmacokinetics services market is expected to reach USD1.2 billion by 2025, registering an 8.3% CAGR during the forecast period.

PromarkerD test and proprietary technology platform provide a scalable licensing model with high margins and at minimal cost.

PIQ plans to commercialise any newly developed tests through an out-licensing model via upfront licence fees and royalty-based revenue on every test sold.

Through use of a licensing model, PIQ plans to leverage the sales and marketing knowledge of their distributors providing access to markets, scalability and reduced cost.

Fundamentals

Market Capitalisation: $39.3M
Shares outstanding: 92.4M

CFS
Free cash flow positive: $572,000 or $52,000 (ignoring deferred grant income)
>4 Q’s of funding available (this must be noted in case FCF turns negative?)

BS
Current ratio: >7
Debt-free
Cash reserves of $3.12M

IS

Revenue from services: $925,060 (up 9% from pcp)

Timeline

2001

Proteomics is established by Dr Richard Lipscombe and Dr Bill Parker and is recognized as a global leader in the field of proteomics.

2009

Proteomics lab is the first in the world to receive ISO 17025 accreditation for proteomic services.

2015

Company lists on the ASX.

2016

Agreement to have Omics Global Solutions distribute PIQs diabetic kidney disease tests in Dominican Republic.

Tests to be manufactured in US territory of Puerto Rico, coming under umbrella of US FDA guidelines providing a potential steppingstone into US and other markets.

Launch of India website as part of PIQ’s strategic marketing initiative to cater to the existing need of the Indian market and drive cash flow through fee-for-service work.

A few key management personnel provide loans to the company at 7% interest (CEO Dr Lipscombe - $428,212 others at $10k and $3k) expiring April 2019.

2017

PIQ completes an oversubscribed $2M capital raising.

Proteomics International's co-founder Dr Bill Parker passes away suddenly in February.

PromarkerD test validated by peer-reviewed scientific journal.

Pharmacokinetic (PK) test services launched (relevance is to therapeutic drug discovery market)

Become world’s most highly accredited protein testing laboratory.

2018

Engaged with number of partners to bring PromarkerD to market as a clinical diagnostic test (IVD or LDT) or companion diagnostic (CDx) in mainland USA, Mexico, Japan, Australia, China and Europe.

Partner with Busselton Population Medical Research Institute to improve the diagnosis and treatment of lung conditions such as asthma and chronic obstructive pulmonary disease (COPD).

90% take-up of PIQs ASX listed options raising $3.4M.

Management predicts strong 2019 financial year.

Proteomics International signs a deal to launch PromarkerD in the USA through a partnership with PrismHealthDx (PHDx), who will launch the LDT version of PromarkerD in its specialist certified laboratories. NOTE – this will eventually fall through

Proteomics International signs a licence agreement with biotech company Patia BioPharma for the LDT version of PromarkerD in Mexico.

Proteomics International discover several potential biomarkers in the blood that could be used to test for endometriosis and plan to progress with research.

2019

Sign a collaborative agreement with Janssen Research & Development, LLC, the research arm of Johnson & Johnson. If the study is successful, PromarkerD may be designated as a Complementary Diagnostic (CDx) test for the treatment of diabetic kidney disease with Janssen’s diabetes drug.

Expand partnership with Linear Clinical Research, signing two new major contracts to conduct pharmacokinetic testing.

2020

Join forces with Bioplatforms Australia and The University of Western Australia to launch a cutting-edge proteomics facility.

PromarkerD, achieves CE Mark registration in Europe for both the immunoassay kit, PromarkerD (IA) and the PromarkerD Hub which will allow laboratories to process much higher numbers of samples at a more cost-effective rate.

Expand diagnostic pipeline to include endometriosis, the Giardia parasite, chronic lung conditions, cancer, oxidative stress, plant dieback, diabetic retinopathy and COVID-19.

Have identified protein ‘fingerprints’ (biomarkers) in the blood that could be used to test for endometriosis with subsequent patent filed.

Patents and IP

The company has patents for the biomarkers identified with pre-diabetes, diabetes and diabetes related conditions; all valid until 2031 in the following countries:

USA

Europe

Australia

China

Indonesia

Singapore

Russia

Japan

Brazil (pending)

India (pending)

Canada (pending)

Hong Kong (pending)

Competitors

There are too many companies operating in the space of proteomics (drug discovery as well as diagnostics) to list. PIQ will have to rely on IP and patents, such as PromarkerD, to stay ahead of competitors. Considering the size and diversity of the addressable market is huge (e.g. oncology, neurology, cardiology, inflammatory, infectious disease etc etc) and with IP and patent protections already in place PIQ should be able to have success.

PIQs Promarker technology platform reduces the risk of being disrupted by tech – as this is already being used within the business.

In early 2019, MDNA Life Sciences announces that it is to launch the world's first blood test for endometriosis, able to detect the disease in up to 9 out of 10 cases. Results will be available in a matter of days after the test is carried out. As far as I know PIQ has not commented on this but this could be a big blow to commercialisation of their own endometriosis test.

R&D Pipeline

The Promarker R&D pipeline and typical timeline is as follows:

Ethics & governance approval (3 months), Discovery (6 months), Proof of concept (6 months), Clinical studies/Validation (12 months)

Endometriosis (patent filed for diagnostic test)

Proof of concept study completed. Clinical studies pending.

Affecting 1 in 9 Australian women, endometriosis occurs when the tissues that line the uterus spread outside of the uterine cavity and surround other organs. The current gold standard detection is a surgical procedure.

Given the large unmet medical need and the only existing diagnostic tool being invasive surgery,

Proteomics International believes there will be significant commercial interest in this program post

successful clinical study validation.

Parasite infections: Giardia

Proof of concept study completed. Validation study pending.

In collaboration with the Murdoch University Veterinary School and a leading US veterinary

company.

Giardia is a leading cause of infectious gastroenteritis worldwide and one of the most common

parasitic human diseases. The risk for human health is that some Giardia strains that affect pets can

cross into humans (zoonotic), whilst others do not (host specific). An estimated 280 million people worldwide are infected each year.

Proteomics International has identified strain specific Giardia targets and developed a prototype

immunoassay, which is pending validation using field samples. The commercial viability is pending these results.

A strain specific test could readily benefit the US market where according to the Centers for

Disease Control and Prevention, the prevalence is an estimated 1.2 million people.

Asthma and chronic obstructive pulmonary disease (COPD)

Ethics approved. Discovery study pending.

Aim to identify biomarkers for asthma and chronic obstructive pulmonary disease in collaboration with the Busselton Population Medical Research Institute.

Plant Dieback (Phytophthora cinnamomi)

Discovery study ongoing.

Proteomics International has an ongoing collaboration with the Centre for Crop and Disease Management, Curtin University to target the plant pathogen Phytophthora cinnamomic responsible for plant dieback.

Already more than 1 million hectares of Western Australian bushland (avocados, macadamias, pineapples) have been infected. Phytophthora attacks the roots and inhibits them from being able to take up water and nutrients, resulting in death (Dieback).

Current investigations are focused on proteomic analysis (determining the protein maps) of the life

stages of the organism and how it infects its host. This has the potential to identify weaknesses in

the pathogen that could be targeted to help eradicate this disease.

Diabetic Retinopathy

Discovery study pending.

Collaboration agreement signed with The University of Western Australia to seek early markers for diabetic retinopathy. A third of diabetic patients have diabetic retinopathy, a vision impairment caused by damage to blood vessels at the back of the eye.

Diabetic retinopathy is the major cause of blindness in the USA and finding and treating it early can reduce the risk of blindness by 95%.

This collaboration will apply the Promarker platform to look for prognostic markers in the blood that

can identify patients at risk of retinopathy utilising the Fremantle Diabetes Study – the same sample repository that led to PromarkerD.

Markers for oxidative stress - '2-tag' technology

Proof of concept study completed. Clinical validation pending.

Biomarkers for cancer

Status update: In-licensing discussion (Proof of concept study completed. Clinical validation pending).

Novel disease biomarkers - ARC Centre for Personalised Therapeutics Technologies

Status update: In-licensing discussion (Ethics approved. Discovery study pending).

COVID-19

Status update: Programs initiated.

Management

PIQ is founder led with 4 PhDs and a very talented and proven team in the field of proteomics, diagnostic testing and global business. Dr Lipscombe’s motives and incentives appear to be well aligned with shareholders (22% ownership) and watching him speak he appears confident and passionate. Board is modestly paid, ignoring share-based compensation - options.

3 members of the board have recently purchased $100,000 worth of shares on-market at a price of $0.41 which gives me confidence the company see progress on the horizon.

Execution is the only question surrounding management as they’ve been unable to commercialise their PromarkerD test for a number of years.

Dr Richard Lipscombe – Co-Founder PhD, MA; approx. 22% ownership

Highly practised business manager and protein chemist expert in analysing bio-molecules using proteomics techniques.

Extensive expertise in chemistry, immunology, mass spectrometry, peptide synthesis, high performance computing and robotics.

International experience in both science and business gained over a 29-year period in Australia, USA and the UK

Completed his chemistry degree (MA) at Oxford University, his PhD in immunology at London University and was a Post-Doctoral scientist (molecular immunology)

Is well published in peer review journals and holds of several patents.

*Dr Lipscombe has exercised the majority of his options since 2016 and appears passionate and aligned with shareholders.

Mr Terry Sweet – Independent Non-Executive Chairman FAICD

Director of several listed companies over the past 30 years in both executive and non-executive capacities, including XRF Scientific Ltd, where he was Managing Director for 4 years, Western Biotechnology Ltd, Heartlink Ltd, and Scientific Services Ltd.

Originally trained as a chemist, his interests and expertise now lie in the area of development and supervision of a culture of Board integrity, commensurate with technology commercialisation.

*XRF appears to have performed well while Mr Sweet was there

Mr Roger Moore – Independent Non-Executive Director R, BPharm

40 years’ experience in the international pharmaceutical industry, including almost 30 years as President of Novo Nordisk Japan.

Mr Moore established Novo’s organisation in Japan as the first employee in 1977 and worked for the company until his retirement as Chairman at the end of 2007. From 2000, Mr Moore was appointed Senior Vice President, Japan and Oceania Region, responsible for Novo Nordisk’s business in Japan, Australia, New Zealand and the Pacific. Also, appointed a member of the Senior Management Board, Novo Nordisk A/S.

Since 2008 has worked to assist selected Australian biotech companies and selected Japanese pharma companies in their international business development activities.

*Novo Nordisk appears to be actively engaged in the diabetes space displaying relevance to his role with PIQ.

Mr Paul House – Independent Non-Executive Director GAICD, BCom

Served eight years as the Managing Director of SGS India, where he was responsible for a workforce of approximately 4,500 personnel across 65 locations in India, including 38 laboratories. SGS is the world’s leading Testing, Inspection and Certification (TIC) company, and operates a network of offices and laboratories in more than 140 countries.

Previously held Chief Financial Officer and COO roles and was Senior Manager for several years at a leading global management consultancy firm.

Mr House has a track record for delivery of business performance targets, revenue growth, margin improvement, market share and productivity, across multiple services, markets and borders.

*Mr House’s previous experience gives PIQ a foot in the door to the Indian biopharma industry.

Dr Pearl Tan (PromarkerD Business Manager)

2013 PhD (Research), Biochemistry and Molecular Biology, UWA
2008 BSc with honours in Biochemistry, UWA, Australia
2007 BSc, Molecular Biology and Biotechnology, UWA, Australia

Dr Scott Bringans (Research Manager)

2001 PhD, Department of Chemistry, University of Canterbury
1997 BSc (Hons), Department of Chemistry, University of Canterbury

Dr Kerryn Garrett (General Manager)

Brings extensive research background in various diseases including muscle and neurodegenerative disorders, eye disease, cancers (prostate, colon, breast, lung, gynaecological and melanoma), using a wide range of molecular and genetic technologies.

2012 FFSc (RCPA) Fellowship Faculty of Science Royal College of Pathologists Australasia
1993 PhD University of Western Australia
1989 BSc (Hons) University of Western Australia
1988 BAppSc (Medical Laboratory Sciences) Curtin University

Mr Chuck Morrison (Head of Business Development)

36 years’ experience in life sciences, biotechnology, and diagnostic industries

Has held several management positions while at NEN Life Sciences and DuPont before focusing his last 15 years in Business Development at PerkinElmer.

MBA, Boston University, Massachusetts, USA

*Based on share price, PerkinElmer appears to have performed very well since 2017