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SYNTARA LIMITED — Investor Presentation 2021
Apr 6, 2021
65830_rns_2021-04-06_bf8859a7-3819-4026-97ef-8f65a3b105ba.pdf
Investor Presentation
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Investor Presentation | April 2021
Gary Phillips CEO
developing breakthrough treatments for fibrosis and inflammation
Forward looking statement
This document contains forward-looking statements, including statements concerning Pharmaxis’ future financial position, plans, and the potential of its products and product candidates, which are based on information and assumptions available to Pharmaxis as of the date of this document. Actual results, performance or achievements could be significantly different from those expressed in, or implied by, these forward-looking statements. All statements, other than statements of historical facts, are forward-looking statements.
These forward-looking statements are not guarantees or predictions of future results, levels of performance, and involve known and unknown risks, uncertainties and other factors, many of which are beyond our control, and which may cause actual results to differ materially from those expressed in the statements contained in this document. For example, despite our efforts there is no certainty that we will be successful in developing or partnering any of the products in our pipeline on commercially acceptable terms, in a timely fashion or at all. Except as required by law we undertake no obligation to update these forwardlooking statements as a result of new information, future events or otherwise.
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Novel, small molecule medicines focused on cancer and fibrotic disease
In House Discovery and Development capability
Experienced team delivering stream of novel drugs to the clinic
Platform technology drives pipeline of clinical assets
Multiple opportunities from global leadership in amine oxidase enzymes
Cash flow positive manufacturing business
FDA approval for Cystic Fibrosis drug transformative with Pharmaxis manufacturing business now cash flow positive
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Clinical stage
medicines
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Targeting Fibrosis
and Cancer
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Lead asset PXS-5505 in phase 2 trial
Breakthrough clinical program with disease modifying potential in Myelofibrosis
Broad potential for PXS-5505 in oncology
Global scientific and clinical collaborations to extend value of PXS5505 in further oncology indications
Anti scarring drug in phase 2 trial in 2021
PXS-6302 to enter patient studies in commercially important dermatology indications
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Experienced Scientific Leadership Team Significant global experience in drug development, commercialisation and partnering
In senior management
On the board
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Wolfgang Jarolimek – Drug Discovery
-
more than 20 years’ experience in pharmaceutical drug discovery and published more than 30 peer reviewed articles
-
previously Director of Assay Development and Compound Profiling at the GlaxoSmithKline Centre of Excellence in Drug Discovery in Verona, Italy
-
spent 8 years as post-doc at the Max-Plank Institute in Munich, Germany; Baylor College of Medicine, Houston, Texas; Rammelkamp Centre, Cleveland Ohio; and University of Heidelberg, Germany
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Gary Phillips – CEO and Managing Director
more than 30 years of operational management experience in the pharmaceutical and healthcare industry in Europe, Asia and Australia joined Pharmaxis in 2003 and was appointed Chief Executive Officer in March 2013 at which time he was Chief Operating Officer
-
previously held country and regional management roles at Novartis – Hungary, Asia Pacific and Australia
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Dieter Hamprecht – Head of Chemistry
- more than 20 years experience with small molecule and peptide experience, contributed to greater than 10 drug candidates brought to development and co-inventor of 50 patent families, co-author of 30+ scientific publications
previously Managing Director – Boehringer Ingelheim’s research group in Milan
- senior medicinal chemistry positions at GSK
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Kathleen Metters – Non Executive Director
former Senior Vice President and Head of Worldwide Basic Research for Merck & Co. with oversight of all the company’s global research projects. in a subsequent role at Merck &Co she led work on External Discovery and Preclinical Sciences
former CEO of biopharmaceutical company Lycera Corp
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Brett Charlton - Medical
more than 25 years experience in clinical trial design and management author of more than 80 scientific papers founding Medical Director of the National Health Sciences Centre previously held various positions with the Australian National University, Stanford University, the Baxter Centre for Medical Research, Royal Melbourne Hospital, and the Walter and Eliza Hall Institute
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Neil Graham – Non Executive Director
-
former VP of immunology and inflammation responsible for strategic program direction overseeing pipeline development and clinical programs at Regeneron (REGN:US)
-
former SVP program and portfolio management at Vertex Pharmaceuticals
-
former Chief Medical Officer at Trimeris Inc and Tibotec Pharmaceuticals
Read more on the Pharmaxis website
Drug development capability
Established team in Drug Discovery and Clinical Trials with broad experience across multiple regulatory agencies
2015-2020
Organisation
-
Leadership with extensive drug discovery/development experience from big pharma and biotech
-
Full In house capabilities
oOn site laboratories -
Leveraged with international network of external contract organisations
-
Numerous collaborations with leading academic institutions in Australia and world-wide in pharmacology and medicinal chemistry
-
High scientific reputation through peer-reviewed publications
-
Direct management of Regulatory interaction with FDA, EMA, etc.
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7 Drugs
entered
pre-clinical
12
testing
publications
4 Drugs
entered
phase 1
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3 Drugs cleared phase 1 / IND ready
Strategy
-
Focus on inflammation and fibrosis/cancer driven diseases with high unmet medical need
-
Leverage global leading position in amine oxidase chemistry and biology
-
Create first / best in class small molecule inhibitors with biomarker assays for early validation of clinical hypothesis in phase 1 trials
-
Protect intellectual property by focused chemical matter, use and biomarker patents
-
Capture advantages of Australian location:
-
Accelerated (and lower cost) Phase 1 entry
-
Australian Government R&D tax credit system
2 Drugs in phase 2
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Multiple potential value inflection points over next two years Pipeline creates multiple opportunities
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Product Candidate 2021 2022 2023
Myelofibrosis Phase 1c Myelofibrosis Phase 2
PXS-5505
MDS pre-clinical MDS Phase 2
Pan-LOX Oncology
Hepatocellular Carcinoma Phase 2
Phase 1 Established / keloid scars Phase 2
PXS-6302
Pan-LOX topical scarring
Post surgical burns scarring Phase 2
PXS-4699 preclinical
Research
assessment by DMD TACT
committee
Phase 2 ready programs
Evaluating grant and partnering
SSAO; PXS-4728
options
LOXL2; PXS-5382
Value inflection point Grant pending
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DMD: Duchenne Muscular Dystrophy
MDS: Myelodysplastic Syndrome
Pipeline opportunities
in fibrosis and inflammation
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PXS-5505 Breakthrough clinical program in
myelofibrosis prioritised into phase 2
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First in class PXS-5505 IND approved and in the clinic
Novel anti fibrotic approach with broad applications in difficult to treat cancers
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Myelofibrosis: Orphan Disease with high unmet need forecast to exceed US$1b
-
Drug with disease modifying potential patented 2018
-
Long term tox and phase 1 studies completed 1H 2020
-
FDA orphan status granted July 2020
-
IND approved August 2020
-
Phase 1/2a proof of concept myelofibrosis study commenced recruitment Q1 21
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Adjunct to best standard of care in multiple cancers
-
Pan-LOX inhibition synergistic with current standard of care and pharma development pipeline in many stromal cancers
-
Academic and clinical interest in additional indications including;
-
Myeloproliferative disorders (e.g. MDS)
-
liver carcinoma (HCC)
-
glioblastoma
-
International studies facilitated by IND approval and availability of drug product
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Myelofibrosis background
A rare type of bone marrow cancer that disrupts your body's normal production of blood cells
KEY FACTS
Primary Myelofibrosis is caused by a build up of scar tissue (fibrosis) in bone marrow reducing the production of blood cells:
- Driven by clonal mutations of a hematopoietic stem cell (JAK, MPL, CALR genes)
Affects 15 in 1m people worldwide
-
Reduced red blood cells can cause extreme tiredness (fatigue) or shortness of breath
-
Reduced white blood cells can lead to an increased number of infections
-
5 Years Median survival
-
Reduced platelets can promote bleeding and/or bruising
-
Spleen increases blood cell production and becomes enlarged
Age of onset 50 – 80
- Other common symptoms include fever, night sweats, and bone pain
Standard of Care; JAK inhibition
11% transformation to leukemia
-
Symptomatic relief plus some limited survival improvement. 75% discontinuation at 5 years
-
Median overall survival is 14 – 16 months after discontinuation
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Mode of action in MF
Disease modifying potential as monotherapy and on top of standard of care
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Unique mechanism of action
targeting the extracellular matrix
Disease modifying
potential
Efficacy on top of
existing standard of care -
AND development pipeline drugs
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“Specific targeting of ECM dysregulation to prevent and diminish MF may prove the frontline of research and therapy development in PMF with the greatest promise of relieving symptoms and extending life expectancy of patients” Blood Cancer Journal (2017) 7, e525; doi:10.1038/bcj.2017.6
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PXS-5505; Pan-LOX inhibitor with promising profile Pre clinical and clinical studies strongly support entry into patient studies
PXS-5505 attenuates hallmarks of primary myelofibrosis in mice.
PXS-5505 – Phase 1 SAD
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Treatment with
PXS-5505
significantly
reduced reticulin
fibrosis
( = p<0.001)
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“JAK inhibition alone is insufficient in the treatment of patients with myelofibrosis; it is not associated with changes in underlying disease biology and it can worsen blood counts, leading to high drug discontinuation rates over time. The trial utilizing PX-5505 is supported by a sound scientific rationale, based on pre-clinical work demonstrating the importance of lysyl oxidase in the development of myelofibrosis. PXS-5505 has a unique mechanism of action that has the potential for disease modification. I am looking forward to seeing the effect of this drug in clinical trials.”[1]
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Good safety profile with 6 month tox studies complete
-
Dose dependant 24 hour inhibition of LOX enzymes from single once a day dose in humans
-
No safety signal seen in phase 1 trials
-
2018 priority patent date
Ref Graph1: Leiva et al. Intl J Hemat 2019. https://doi.org/10.1007/s12185-019-02751-6
PXS-5505 Phase 1/2a Trial in myelofibrosis
6 month monotherapy study with meaningful safety and efficacy endpoints
STUDY POPULATION
DESIGN
JAK-inhibitor unsuitable* Phase 1/2a open primary MF or post-ET/PV label study to MF patients with: evaluate safety, PK/PD, and efficacy
-
INT-2 or High risk MF requiring therapy
-
Symptomatic
-
BMF Grade 2 or greater
TREATMENT COHORT
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Dose escalation: PXS-5505 3 ascending doses, 4 weeks (n = 3 to 6 subjects/dose)
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Cohort expansion: PXS-5505 (n = 24 subjects) 26 weeks
ENDPOINTS
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Primary: Safety TEAEs
Secondary: PK/PD BMF Grade IWG Response SVR Haematology Symptom score
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FDA granted orphan drug designation July 20 and IND approved August 2020
Multiple sites across 3 countries to enhance trial recruitment (USA, Korea, Australia)
Study budget (~US$5m)
Study recruitment commenced Q1 2021, study concludes H2 2022
*Unsuitable = ineligible for JAKi treatment, intolerant of JAKi treatment, relapsed during JAKi treatment, or refractory to JAKi treatment. JAKi – Janus Kinase inhibitor, MF myelofibrosis, ET Essential Thrombocythaemia, PV polycythaemia vera, INT intermediate,
BMF bone marrow fibrosis, RP2D recommended phase 2 dose, TEAE treatment emergent adverse event, PK pharmacokinetics, PD pharmacodynamics, SVR spleen volume response, IWG International Working Group Myeloproliferative Neoplasms
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Myelofibrosis – other programs
PXS-5505 unique mechanism of action promises disease modification and good tolerability
| Company | Market cap(1) | Bourse | Asset | Description | Clinical phase |
|---|---|---|---|---|---|
| $1.2bn | Nasdaq | KER-050 | TGF-β ligand trap | Phase 2 | |
| $1.1bn | Nasdaq | CPI-0610 | BET inhibitor | Phase 3 | |
| $0.7bn(2) | n.a. – private | KRT-232 | MDM2 antagonist | Phase 3 | |
| $0.5bn | Nasdaq | Imetelstat | Telomerase inhibitor | Phase 3 | |
| $27m (A$35m) | ASX | PXS-5505 | Pan-LOX inhibitor | Phase 1c/2 commenced |
|
| Existing pipeline in development all have challenging safety / side effect profiles PXS-5505 unique mechanism of action with expected good efficacy AND tolerability PXS-5505 mechanism of action expected to deliver additional efficacy on top of existing standard of care and/or known pipeline drugs without adding to tolerability issues |
Notes: (1) Market cap as at 1[st] October 2020
Pipeline opportunities
in fibrosis and inflammation
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PXS-5505 Significant opportunity in other cancers;
-
Myelodysplastic Syndrome
-
Hepatocellular Carcinoma
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PXS-5505: Significant opportunity in other cancers
Global academic and clinical interest in LOX inhibition drives development plan
Normal tissue
Pharmaxis Research Collaborations
Other Myeloproliferative Disorders; e.g.
Myelodysplastic syndrome
Germany
Liver Cancer
Rochester (NY)
Pancreatic Cancer
Sydney, Rochester (NY)
Melanoma and glioblastoma Houston
Head and Neck Cancer
Boston
Mesothelioma
Dublin
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Collagen
Tumour with fibrotic tissue has
• increased tissue stiffness
• Increased interstitial pressure
Increased Increased
EMT angiogenesis
Increased Decreased
Increased
Invasion drug perfusion
tumour growth
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Multiple benefits from anti-fibrotic mechanism of action
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EMT: epithelial to mesenchymal transition 15
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Myelodysplastic Syndrome (MDS)
A rare type of bone marrow cancer that disrupts your body's normal production of blood cells
KEY FACTS
A group of malignant hematopoietic neoplasms characterized by Bone marrow failure with resultant cytopenia and related complications
Current standard of care
Affects ~40 in 100,000 people > 70 years
-
Allogeneic stem cell transplantation
-
Immunomodulatory drug lenalidomide,
-
Advanced disease: DNA hypomethylating agents (HMA), azacitidine (AZA), and decitabine
50% to 60% of the patients will die from complications of the disease
New US diagnoses per annum ~50,000
30% transformation to Acute Myeloid Leukemia
Pre clinical evidence
-
Unpublished data from Pharmaxis scientific collaborations demonstrating strong proof of concept
-
– Treatment with PXS-5505 and AZA significantly increases red cell count
Clinical strategy
-
6 month open label study in patients non responsive to AZA / current standard of care
-
Multi centre approach to follow on from myelofibrosis study
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Hepatocellular Carcinoma (HCC)
4th leading cause of cancer-related mortality worldwide with a 19.6% 5-year relative survival
- Primary liver malignancies have doubled in incidence over the last two decades.
HCC is a stromal (fibrotic) tumour
- Accumulation of collagen crosslinks increases stromal stiffening and interstitial fluid pressure (IFP) reducing delivery of chemotherapy and immunotherapy.
Etiology
-
Extrinsic factors e.g. Virus infections
-
Intrinsic factors e.g. auto immune diseases, fatty infiltration, genetics
Current standard of care
-
Tyrosine kinase inhibitors
-
PD-L1 inhibitors + anti-VEGF
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Pre-clinical data
-
High LOX expression associated with reduced survival
-
LOX is up-stream regulator of VEGF expression and inhibition of this enzyme could potentiate the intratumoral effects of anti-VEGF therapy
-
Combination anti-PD-1 therapy with LOX inhibition has demonstrated synergistic decrease in tumor growth
Clinical strategy
Enhance the intratumoral response to VEGF therapy and anti-PD-L1 blockade through the addition of LOX inhibition in human HCC
-
Open label 6 month study combination PXS-5505 with Atezolizumab and Bevacizumab compared to historical standard of care in newly diagnosed unresectable or metastatic hepatocellular carcinoma
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Pipeline opportunities
in fibrosis and inflammation
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PXS-6302 Topical Pan-LOX Inhibition for
scarring
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Hypertrophic and keloid scarring
Cutaneous scarring following skin trauma or a wound is a major cause of morbidity and disfigurement
KEY FACTS
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Collagen turnover in keloid
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- Mechanisms underlying scar formation are not well established, and prophylactic and treatment strategies remain unsatisfactory
Current standard of care
100m patients develop scars in the developed world alone each year as a result of elective operations and operations after trauma
Hypertrophic scars and keloids are fibroproliferative disorders that may arise after any deep cutaneous injury caused by trauma, burns, surgery, etc.
Hypertrophic scars and keloids are cosmetically and functionally problematic significantly affecting patients’ quality of life
The increase in extracellular matrix is a key factor and this depends on collagen and elastin cross-linking to make them less degradable.
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-
Corticosteroids
-
Surgical revision
-
Cryotherapy
-
Laser therapy
-
5-fluorouracil
Pre clinical evidence
-
Unpublished data from Pharmaxis scientific collaborations demonstrating strong proof of concept
-
– Treatment with PXS-6302 monotherapy and tool compound demonstrates cosmetic and functional improvements to the scar
Clinical strategy
-
3 month placebo controlled study in patients versus current standard of care.
-
Initial patient groups will either have established scars or scarring subsequent to burn injury.
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Further non core pipeline opportunities in fibrosis and inflammation Leveraging global leadership position in amine oxidase enzymes to deliver targeted drugs for cancer and fibrosis
| Product Candidate Indications Pre- clinical |
Product Candidate Indications Pre- clinical |
Product Candidate Indications Pre- clinical |
Phase 1 | Phase 2 Next Steps |
Phase 2 Next Steps |
|---|---|---|---|---|---|
| SSAO; PXS-4728 | Repurposed for neuro inflammatory disease |
• Partnering discussions; phase 2 protocol and funding discussions with independent investigators |
|||
| LOXL-2; PXS-5382 | Chronic fibrotic disease e.g. chronic kidney disease, idiopathic pulmonary fibrosis |
• Partnering discussions; phase 2 protocol and funding discussions with independent investigators |
|||
| SSAO/MAOB; PXS-4699 | Anti inflammatory Muscular Dystrophy |
• $1m matched funding grant • DMD TACT committee Q2 2021 • Advance to the clinic H1 2022 |
|||
| SSAO/MPO; PXS-5370 | Anti inflammatory Multiple indications |
• Grant identification in process |
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IIS: Independent Investigator Studies 20
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Mannitol respiratory business (Bronchitol® and Aridol®)
Transformational impact of FDA Bronchitol approval (Oct 2020) - cash flow positive from FY 2021 onwards
Sales
-
Mannitol respiratory sales forecast to double by FY 2022 with Bronchitol > 75% of sales
-
Strong longer term growth contribution from US
-
Growth in Ex-US markets including Russia
Expenses
-
Relatively fixed production cost base
-
Potential for simplified business
-
model to reduce costs
EBITDA
-
Positive EBITDA from FY 2021 onwards (before potential cost savings).
-
US volumes enable mannitol segment to generate profit
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Bronchitol in US
- US CF market >65% of global market
US market doubles global cystic fibrosis patient opportunity with attractive pricing
-
Chiesi approval /launch milestone payments US$10m received FY 2021
-
US sales commence in Q2 CY 2021
-
High teens % of Chiesi sales + long term supply contract - ~20% of Chiesi US Bronchitol net sales flow directly to the Pharmaxis bottom line
-
Three sales milestones totaling US$15m payable on achieving annual sales thresholds
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Strengthened cash position
Further opportunities to extend cash runway ahead
-
Dec 20 proforma cash balance of A$22m
-
Cash Dec 2020: A$18m (includes $4m Chiesi milestone received March 2021)
-
US Bronchitol sales commence in Q2 CY 2021
-
High teens % of Chiesi sales + long term supply contract - ~20% of Chiesi US Bronchitol net sales flow directly to the Pharmaxis bottom line
-
Mannitol business to go from cash burn (FY 20: A$4m) to cash flow positive from FY 21 onwards (FY 26: A$10m+)
| Year | 2019 | 2020 | From 2021 E |
|---|---|---|---|
| EBITDA (A$m)* |
($5.0) | ($4.0) | Cash Flow Positive |
-
Further opportunities to extend cash runway
-
Mannitol potential cost savings
-
Distribution license fees from additional Aridol and Bronchitol territories
-
Pipeline supported by grants and R&D tax credit (~A$5m 2020)
-
Partnering deals with pipeline assets
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Proforma Cash Usage [1] A$m
20
18
16 ($5m)
14 Mannitol makes a
($4m)
positive cash
12
contribution from
10
FY 21 onwards
8
6
4
2
0
2019 2020 Future
Other Mannitol
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- Proforma cash usage is the total of segment EBITDA (mannitol business, new drug discovery and corporate), finance lease payments, capex and financing agreement payments. Refer financial slides for further detail.
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Mannitol segment EBITDA only 22
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Anticipated news flow: 2021 – 2022 Multiple value inflection points over next two years
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H1 2021
-
Feb 22: Breakthrough drug PXS-5505 phase 1c/2a myelofibrosis study commenced recruitment
-
Mar 19: Chiesi pays US$3m milestone on Pharmaxis shipment of US launch
-
Mar 31: LOX topical drug PXS-6302 commenced independent investigator studies - safety
-
Mannitol business simplification completed – realising annual cost savings
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H2 2021
CY 2022
-
PXS-5505 phase 1c/2a myelofibrosis study dose expansion stage commence
-
PXS-5505 phase 2a myelofibrosis study safety and efficacy data
-
First collaborations to progress PXS-5505 into clinical trials in other myeloproliferative diseases and/or cancer indications
-
PXS-5505 dose escalation data in myelodysplastic syndrome
-
PXS-5505 dose escalation data in hepatocellular carcinoma
-
Ongoing cash receipts from supply of Bronchitol for US sales
-
LOX topical drug phase 2 studies burns and established scars safety and efficacy data
-
LOX topical drug progresses into independent investigator patient studies - burns and established scars
-
Feedback from global advisory committee on development fast tracking for Duchenne muscular dystrophy clinical trials.
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Appendices
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Experienced senior management team
Significant experience in drug development, commercialisation and partnering
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Gary Phillips – CEO
-
more than 30 years of operational management experience in the pharmaceutical and healthcare industry in Europe, Asia and Australia
-
joined Pharmaxis in 2003 and was appointed Chief Executive Officer in March 2013 at which time he was Chief Operating Officer
previously held country and regional management roles at Novartis – Hungary, Asia Pacific and Australia
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Wolfgang Jarolimek – Drug Discovery
-
more than 20 years’ experience in pharmaceutical drug discovery and published more than 30 peer reviewed articles
-
previously Director of Assay Development and Compound Profiling at the GlaxoSmithKline Centre of Excellence in Drug Discovery in Verona, Italy
spent 8 years as post-doc at the Max-Plank Institute in Munich, Germany; Baylor College of Medicine, Houston, Texas; Rammelkamp Centre, Cleveland Ohio; and University of Heidelberg, Germany
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David McGarvey – CFO
• more than 30 years’ experience building Australian based companies from inception to globally successful enterprises
-
joined Pharmaxis as Chief Financial Officer and Company Secretary in December 2002
-
previously Chief Financial Officer of the Filtration and Separations Division of US Filter (1998-2002), and Memtec Limited (1985-1998)
-
• commenced career at PricewaterhouseCoopers
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Kristen Morgan – Alliance Management
more than 20 years’ experience in the pharmaceutical industry having previously held a senior role in medical affairs at Sanofi-Aventis, and a commercial sales role at GlaxoSmithKline
-
responsibility for alliance management and medical and regulatory affairs
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Brett Charlton - Medical
more than 25 years experience in clinical trial design and management author of more than 80 scientific papers founding Medical Director of the National Health Sciences Centre previously held various positions with the Australian National University, Stanford University, the Baxter Centre for Medical Research, Royal Melbourne Hospital, and the Walter and Eliza Hall Institute
Non Executive Directors
Malcolm McComas Kathleen Metters Will Delaat Neil Graham – Chair, former former head of former CEO of Merck former strategic investment banker; worldwide basic Australia; former chair program director at former MD Citi Group research at Merck; of Medicines Australia Regeneron Inc; former CEO of extensive career in biopharmaceutical pipeline development company Lycera Corp and clinical development
Read more on the Pharmaxis website
Board
Significant international pharmaceutical experience
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Malcolm McComas – Chair
-
former investment banker and commercial lawyer
-
former MD Citi Group
-
has worked with many high growth companies across various industry sectors and has experience in equity and debt finance, acquisitions and divestments and privatisations.
-
joined Pharmaxis Board in 2003
-
chair since 2012
Will Delaat – Non-Executive Director
-
more than 35 years’ experience in the global pharmaceutical industry
-
former CEO of Merck Australia
-
former chair of Medicines Australia and Pharmaceuticals Industry Council
-
joined Pharmaxis Board in 2008
Dr Kathleen Metters – Non-Executive Director
-
former Senior Vice President and Head of Worldwide Basic Research for Merck & Co. with oversight of all the company’s global research projects.
-
in a subsequent role at Merck &Co she led work on External Discovery and Preclinical Sciences
-
former CEO of biopharmaceutical company Lycera Corp
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Gary Phillips – Chief Executive Officer
more than 30 years of operational management experience in the pharmaceutical and healthcare industry in Europe, Asia and Australia joined Pharmaxis in 2003 and was appointed Chief Executive Officer in March 2013 at which time he was Chief Operating Officer
previously held country and regional management roles at Novartis – Hungary, Asia Pacific and Australia
Dr Neil Graham – Non-Executive Director
former VP of immunology and inflammation responsible for strategic program direction overseeing pipeline development and clinical programs at Regeneron (REGN:US)
former SVP program and portfolio management at Vertex Pharmaceuticals former Chief Medical Officer at Trimeris Inc and Tibotec Pharmaceuticals
Read more on the Pharmaxis website
Financials
Cash
| Periods ended (A$’000) | Dec 2020 HY |
Dec 2019 HY |
Jun 2020 FY |
Jun 2019 FY |
|---|---|---|---|---|
| Proforma cash | ||||
| Cashperiod end | 18,249 | 25,864 | 14,764 | 31,124 |
| R&D tax credit | - | - | 5,048 | 5,962 |
| Chiesi milestonepayments | ~4,0001 | - | ~14,000 | - |
| ~$22,249 | $25,864 | ~$33,812 | $37,086 | |
| Cash Flow Statement Highlights | ||||
| Operations | ||||
| Receipts from customers | 3,602 | 3,973 | 7,775 | 6,893 |
| R&D tax incentive | 5,099 | 6,221 | 6,271 | - |
| Chiesi milestone | 9,949 | - | - | - |
| Payments to suppliers,employees etc | (13,602) | (13,886) | (27,330) | (26,691) |
| Total operations | 5,048 | (3,692) | (13,284) | (19,798) |
| Investing (capex) | (281) | (328) | (574) | (981) |
| Finance leasepayments2 | (1,147) | (1,111) | (2,232) | (1,593) |
| Financingagreementpayments3 | (135) | (129) | (270) | (254) |
| Share issue - net | - | - | - | 22,677 |
| Net increase(decrease)in cash | $3,485 | ($5,260) | ($16,360) | $51 |
-
US$3m milestone earned February 2021
-
Lease over 20 Rodborough Rd (to 2024) – total liability at 31 December 2020: $7.1 million
-
NovaQuest financing – not repayable other than as % of US & EU Bronchitol revenue – up to 7 years
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Refer to Quarterly Shareholder Updates, 2020 Annual Report and December 2020 Half Year Report for complete financial information 27
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Financials
Income statement highlights
| Periods ended (A$’000) | Dec 2020 HY |
Dec 2019 HY |
Jun 2020 FY |
Jun 2019 FY |
|---|---|---|---|---|
| Segment Financials | ||||
| New drug development | ||||
| Oral Pan-LOX (external costs) | (1,323) | (1,400) | (3,124) | (3,833) |
| Otherprogram external costs(net ofgrants) | (775) | (1,078) | (3,315) | (5,108) |
| Employee costs | (1,799) | (1,529) | (3,373) | (2,837) |
| Overhead | (238) | (281) | (460) | (606) |
| R&D tax credit | 148 | 259 | 5,159 | 5,962 |
| EBITDA | (3,987) | (4,029) | (5,113) | (6,764) |
| Mannitol respiratory business | ||||
| Sales | 3,086 | 3,259 | 7,027 | 5,676 |
| Other income | 10,098 | 10 | 20 | 27 |
| 13,184 | 3,269 | 7,047 | 5,703 | |
| Expenses – employee costs | (2,914) | (3,037) | (5,855) | (6,083) |
| Expenses– manufacturing purchases | (1,172) | (746) | (1,456) | (1,689) |
| Expenses – other | (2,374) | (1,755) | (3,713) | (2,944) |
| EBITDA | 6,724 | (2,269) | (3,977) | (5,013) |
| Corporate – EBITDA | (2,024) | (1,701) | (2,990) | (3,874) |
| Total Adjusted EBITDA | 713 | (7,999) | (12,080) | (15,651) |
| Net profit(loss) | $46 | ($10,319) | ($13,943) | ($20,058) |
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Refer to Quarterly Shareholder Updates, 2020 Annual Report and December 2020 Half Year Report for complete financial information 28
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Shareholders & trading
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| Financial Information | Institutional Ownership | 31 Dec 20 | ||
|---|---|---|---|---|
| ASX Code | PXS | |||
| BVF Partners (US) | 19% | |||
| Market Cap1 | A$32m | |||
| Shares on Issue1 | 397m | |||
| D&A Income Limited | 7% | |||
| Employee Options1 | 19m | |||
| Liquidity (turnover last 12 months)1 | 369m shares | Other Institutions | 8% | |
| Share price1 | A$0.081 | |||
| Proforma cash balance (31 December 2020) | A$22m | Total Institutional Ownership | 34% |
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1. As at 31 March 2021
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developing breakthrough treatments for fibrosis and inflammation www.pharmaxis.com.au
Contacts
Gary Phillips
Chief Executive Officer
[email protected]
David McGarvey
Chief Financial Officer
[email protected]