Skip to main content

AI assistant

Sign in to chat with this filing

The assistant answers questions, extracts KPIs, and summarises risk factors directly from the filing text.

SYNTARA LIMITED Investor Presentation 2021

Nov 16, 2021

65830_rns_2021-11-16_cc932e4a-b5ef-4cce-aa40-735540c88976.pdf

Investor Presentation

Open in viewer

Opens in your device viewer

==> picture [926 x 31] intentionally omitted <==

Investor Presentation | 17 November 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.

==> picture [960 x 51] intentionally omitted <==

----- Start of picture text -----

2
----- End of picture text -----

Capital Raising

==> picture [207 x 9] intentionally omitted <==

==> picture [926 x 31] intentionally omitted <==

3

Offer Summary

  • Placement to raise approximately $7.2 million (approximately 68.2 million shares), representing 15% of issued capital, to institutional and sophisticated investors (the Placement )

Offer structure and Size

  • The Placement is issued under the Company’s available capacity pursuant to ASX Listing Rule 7.1

  • • Share Purchase Plan ( SPP ) to raise approximately $2.0 million to eligible shareholders[1] • The Placement and SPP are together referred to as the Offer

  • Offer Price of $0.105 per share represents a:

  • 12.4% discount to the VWAP of $0.1198 on Friday, 12 November 2021;

Offer Price

  • 12.0% discount to the 5-day VWAP of $0.1193; and

  • 11.9% discount to the 10-day VWAP of $0.1191

  • 10.9% discount to the 15-day VWAP of $0.1178

Use of Funds

  • Proceeds raised will be used to fund trials and for working capital

  • Lead Manager • Morgans Corporate Limited

  • Ranking and Distribution • New shares issued under the Offer will rank pari-passu with existing fully paid ordinary shares on issue

  • Further information regarding the SPP will be provided in the SPP booklet

==> picture [960 x 51] intentionally omitted <==

----- Start of picture text -----

4
----- End of picture text -----

Indicative Timetable

Event Date
Trading Halt Monday, 15 November 2021
Record Date for SPP 7.00pm Tuesday, 16 November 2021
Announce results of the Placement and resume normal trading Wednesday, 17 November 2021
Settlement of shares issued under the Placement Tuesday, 23 November 2021
Allotment, quotation and trading of shares issued under the Placement Wednesday, 24 November 2021
Despatch of the SPP Booklet and SPP Opening Date Thursday, 25 November 2021
SPP Closing Date 5.00pm Wednesday, 15 December 2021
Announcement of SPP results Monday, 20 December 2021
Issue Date Tuesday, 21 December 2021
SPP Shares issued under the SPP commence trading on ASX Wednesday, 22 December 2021
Despatch of holding statements in respect of the SPP Shares issued under the SPP In the week commencing Monday, 3 January
2022

Note: Dates and times are indicative only and subject to change without notice. Pharmaxis Ltd reserves the right to alter the dates in this presentation at its discretion and without notice, subject to the ASX Listing Rules and the Corporations Act 2001 (Cth). All dates refer to Sydney, Australia time.

==> picture [960 x 51] intentionally omitted <==

----- Start of picture text -----

5
----- End of picture text -----

Executive Summary

  • Pharmaxis is a clinical stage drug development company targeting fibrosis and cancer indications with first in class or best in class small molecule drugs in markets of high value

  • Lead asset PXS-5505 is in phase 2 trial – a breakthrough clinical program with disease modifying potential in Myelofibrosis

  • IND approval to commence US investigator led phase 2 trial in liver cancer with PXS-5505 as first line treatment added to existing chemotherapy.

  • Topical drug PXS-6302 progressing to phase 1c trial in patients with potential to improve function and appearance of scars

  • Specific corporate strategy to deliver non-dilutive cash and cost savings from commercial stage mannitol business;

  • Pharmaxis is in a strong position to fund its focused clinical program

==> picture [319 x 359] intentionally omitted <==

----- Start of picture text -----

Clinical stage
medicines
Targeting fibrosis
and cancer
----- End of picture text -----

==> picture [960 x 51] intentionally omitted <==

----- Start of picture text -----

6
----- End of picture text -----

Shareholders & cash

==> picture [94 x 42] intentionally omitted <==

Financial Information 15 Nov 21
ASX Code
PXS
Share price
$0.115
Liquidity (turnover last 12 months)
323m shares
Market Cap
A$52m
Cash balance (30 Sept 2021)
A$16m
Enterprise value
A$36m
Clinical development program supported by:
  • Mannitol business* forecast to provide ongoing positive EBITDA growing to $10m in 5 - 6 years

  • R&D tax credits

  • Strategy of partnering deals with pipeline assets

Institutional Ownership 30 Sep 21
BVF Partners LP 19%
Karst Peak Capital Limited 12%
D&A Income Limited 7%
Total Institutional Ownership 38%

Share Price

==> picture [360 x 193] intentionally omitted <==

----- Start of picture text -----

$0.16 40
$0.14 35
$0.12 30
$0.10 25
$0.08 20
$0.06 15
$0.04 10
$0.02 5
$- -
Volume ClosePrice
Millions
----- End of picture text -----

==> picture [960 x 51] intentionally omitted <==

----- Start of picture text -----

Mannitol segment EBITDA only 7
----- End of picture text -----*

Experienced Scientific Leadership Team

Significant global experience in drug development, commercialisation and partnering

In senior management

On the board

==> picture [74 x 95] intentionally omitted <==

Wolfgang Jarolimek – Drug Discovery

  • 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

==> picture [73 x 94] intentionally omitted <==

Gary Phillips – CEO and Managing Director

  • 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

==> picture [73 x 100] intentionally omitted <==

Dieter Hamprecht – Head of Chemistry

  • 20+ years’ experience with small molecule and peptide drug discovery, 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

==> picture [74 x 92] intentionally omitted <==

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

==> picture [73 x 101] intentionally omitted <==

Brett Charlton - Medical

 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

==> picture [73 x 102] intentionally omitted <==

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

Multiple potential value inflection points over next two

years Pipeline creates multiple opportunities in high value markets

Target timelines

timelines
Product 2021 2022 2023
PXS-5505
LOX Oncology
Myelofibrosis Phase 1c
Liver cancer (HC
Liver cancer (HC
PXS-6302
LOX topical scarring
Phase 1
Est
e 1c
Est
PXS-4699
DMD Preclinical
DMD pre-clinical
Phase 2 ready
PXS-4728: SSAO
PXS-5382: LOXL2
partnering options
Evaluating grant and partnering options

==> picture [22 x 28] intentionally omitted <==

Potential value inflection point

==> picture [36 x 28] intentionally omitted <==

Negotiating Investigator led clinical trial with University of Rochester

DMD: Duchenne Muscular Dystrophy

HCC: Hepatocellular Carcinoma

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

Age of onset 50 – 80 11% transformation to leukemia

  • Reduced platelets can promote bleeding and/or bruising

  • Spleen increases blood cell production and becomes enlarged

  • Other common symptoms include fever, night sweats, and bone pain

Standard of Care; JAK inhibition

  • Current standard of care; revenue ~US$1b per annum

  • • Symptomatic relief plus some limited survival improvement. 75% discontinuation at 5 years

  • Median overall survival is 14 – 16 months after discontinuation

==> picture [960 x 51] intentionally omitted <==

----- Start of picture text -----

10
----- End of picture text -----

PXS-5505; An effective and safe inhibitor of LOX in myelofibrosis patients Pre clinical and clinical studies strongly support entry into long term phase 2 patient studies

PXS-5505 attenuates hallmarks of primary myelofibrosis in mice

PXS-5505 – Phase 1c dose escalation in MF patients

==> picture [130 x 130] intentionally omitted <==

----- Start of picture text -----

Treatment with
PXS-5505
significantly
reduced reticulin
fibrosis
( = p<0.001)
*----- End of picture text -----

“None of the drugs approved to date consistently or meaningfully alter the fibrosis that defines this disease. PXS-5505 has a novel mechanism of action by fully inhibiting all LOX enzymes.

Preliminary data thus far, demonstrate that PXS-5505 leads to a dramatic, >90% inhibition of LOX and LOXL2 at one week and 28 days. This confirms what’s been shown in healthy controls as well as mouse models, that this drug can inhibit the LOX enzymes in patients. Inhibiting these enzymes is a novel approach to the treatment of myelofibrosis by preventing the deposition of fibrosis and ultimately reversing the fibrosis that characterizes this disease”

Dr Gabriela Hobbs[1]

==> picture [309 x 247] intentionally omitted <==

==> picture [32 x 48] intentionally omitted <==

----- Start of picture text -----

Dose 1
Dose 2
Dose 3
----- End of picture text -----

==> picture [33 x 9] intentionally omitted <==

==> picture [33 x 9] intentionally omitted <==

==> picture [33 x 9] intentionally omitted <==

  • Open label dose expansion in JAK-inhibitor unsuitable[2] primary MF or post-ET/PV MF patients

  • Maximum of 3 patients on each dose for 28 days

  • Good safety profile with no adverse events at highest dose

  • 90% inhibition of LOX and LOXL2 at trough on highest dose at day 7 and 28

Ref Graph1: Leiva et al. Intl J Hemat 2019. https://doi.org/10.1007/s12185-019-02751-6 1 Assistant Professor, Medicine, Harvard Medical School & Clinical Director, Leukaemia, Massachusetts General Hospital

PXS-5505 Phase 1/2a Trial in myelofibrosis

6 month monotherapy study with meaningful safety and efficacy endpoints (phase 1c complete)

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

ENDPOINTS

==> picture [467 x 227] intentionally omitted <==

----- Start of picture text -----

Dose escalation: Primary: Safety TEAEs
PXS-5505
3 ascending doses, 4 weeks Secondary:
(n = 3 to 6 subjects/dose)
PK/PD
BMF Grade
IWG Response
SVR
Cohort expansion:
Haematology
PXS-5505
(n = 24 subjects) 26 weeks Symptom score
----- End of picture text -----

FDA granted orphan drug designation July 20 and IND approved August 2020

Multiple sites across 4 countries to enhance trial recruitment (USA, South Korea, Taiwan, Australia)

Study budget (~US$6m)

Study recruitment commenced Q1 2021, study targeted to conclude 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

==> picture [960 x 51] intentionally omitted <==

----- Start of picture text -----

12
----- End of picture text -----

Myelofibrosis – examples of other programs

PXS-5505 unique mechanism of action designed for disease modification and good tolerability

Company Market cap(1) Bourse Asset Description Clinical phase
$0.9bn Nasdaq KER-050 TGF-β ligand trap Phase 2
$1.6bn Nasdaq CPI-0610 BET inhibitor Phase 3
$0.7bn(2) n.a. – private KRT-232 MDM2 antagonist Phase 3
$0.4bn Nasdaq Imetelstat Telomerase inhibitor Phase 3
$43m (A$57m) ASX PXS-5505 LOX inhibitor Phase 1c/2
commenced
PXS-5505 unique 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) Approximate market cap as at 06 September 2021

PXS-5505: Significant opportunity in other cancers

Global academic and clinical interest in LOX inhibition drives development plan

Normal tissue

Pharmaxis Research Collaborations

Myelodysplastic syndrome

Germany

Liver Cancer Rochester (NY)

Pancreatic Cancer

Sydney, Rochester (NY)

Melanoma and glioblastoma Houston

Head and Neck Cancer Boston, (MA)

==> picture [400 x 284] intentionally omitted <==

----- Start of picture text -----

Collagen
Tumour with fibrotic tissue has
• increased tissue stiffness
• Increased interstitial pressure
Increased Increased
EMT angiogenesis
Increased Decreased
Increased
Invasion drug perfusion
tumour growth
----- End of picture text -----

Multiple expected benefits from inhibition of LOX enzymes

==> picture [960 x 51] intentionally omitted <==

----- Start of picture text -----

EMT: epithelial to mesenchymal transition 14
----- End of picture text -----

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.

  • 4th leading cause of cancerrelated mortality worldwide with a 19.6% 5-year relative survival

  • HCC is a stromal (fibrotic) tumour

Accumulation of collagen cross-links increases stromal stiffening and interstitial fluid pressure reducing delivery of chemotherapy and immunotherapy

 Current standard of care

20-30% are resectable at presentation with many patients relying on systemic therapy:

  • Tyrosine kinase inhibitors

  • PD-L1 inhibitors + anti-VEGF

==> picture [346 x 241] intentionally omitted <==

Commercial Opportunity Drugs market currently worth ~US$2bn with rising incidence forecasted to drive growth to ~US$7bn by 2027

  • Pre-clinical data (Rochester Uni; Aug 2021)

  • Tumour tissue specimens show LOX enzymes are significantly elevated in human liver cancer and correlate with poor prognosis.

  • PXS-5505 with or without chemotherapy treatment in a pre-clinical model significantly improves survival, delays tumor growth, and reduces intratumoral pressure.

 Proposed clinical strategy

  • Enhance the intratumoral response to standard of care through the addition of LOX inhibition in human HCC

  • 6 month study combination PXS-5505 on top of standard of care in newly diagnosed unresectable or metastatic hepatocellular carcinoma

  • Investigator led trial – University of Rochester. Cost ~US$2.5m

==> picture [960 x 51] intentionally omitted <==

----- Start of picture text -----

15
----- End of picture text -----

Hypertrophic and keloid scarring

Cutaneous scarring following skin trauma or a wound is a major cause of morbidity and disfigurement

KEY FACTS

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

Total scar treatment market in 2019 exceeded US$19b. Keloid and hypertrophic scar segment ~US$3.5b

Collagen turnover in keloid

The increase in extracellular matrix is a key factor and this depends on collagen and elastin cross-linking to make them less degradable.

  • Mechanisms underlying scar formation are not well established; prophylactic and treatment strategies remain unsatisfactory

 Current standard of care includes:

  • Corticosteroids

==> picture [145 x 88] intentionally omitted <==

  • Surgical revision

  • Cryotherapy

  • Laser therapy

  • 5-fluorouracil

 Pre clinical evidence

  • Treatment with PXS-6302 monotherapy demonstrates cosmetic and functional improvements to scarring in pre clinical models (data on file)

 Clinical evidence

  • 1 month phase 1a in healthy volunteers demonstrates good tolerability and full inhibition of LOX in skin.

 Next Steps

  • 3 month study versus placebo in patients with established scars to commence Q4 2021

  • Study to investigate scarring subsequent to burn injury to follow in 2022

==> picture [960 x 51] intentionally omitted <==

----- Start of picture text -----

16
----- End of picture text -----

Anticipated news flow: 2021 – 2022

Multiple anticipated value inflection points

==> picture [23 x 23] intentionally omitted <==

PXS-5505 – anti cancer drug

  • PXS-5505 phase 1c liver cancer (HCC) study – starts recruitment

  • PXS-5505 phase 2a myelofibrosis study – fully recruited

  • PXS-5505 phase 2a myelofibrosis study safety and efficacy data

  • PXS-5505 publications by KOL’s in other cancers

==> picture [24 x 23] intentionally omitted <==

==> picture [23 x 23] intentionally omitted <==

Other

PXS-6302 – scar treatment

  • Mannitol business simplification – realising annual cost savings

  • LOX topical drug PXS-6302 commences independent investigator patient studies - established scars

  • Mannitol business – appointment of new distributors

  • LOX topical drug PXS-6302 commences independent investigator patient studies - burns scars

    • Decision by Aptar whether to exercise (by Aug 22) option to license high payload inhaler for US$2.5m plus royalties
  • LOX topical drug PXS-6302 patient studies fully recruited – established and burns scars

  • PXS-6302 publications by KOL’s in scarring

  • Results of Charlie Teo Foundation funded research into PXS-5505 in glioblastoma

==> picture [960 x 131] intentionally omitted <==

==> picture [926 x 31] intentionally omitted <==

developing breakthrough treatments for fibrosis and inflammation Pharmaxis Ltd ABN 75 082 811 630 www.pharmaxis.com.au

Contacts
Gary Phillips
Chief Executive Officer
[email protected]
David McGarvey
Chief Financial Officer
[email protected]
Additional Information

==> picture [207 x 9] intentionally omitted <==

==> picture [926 x 31] intentionally omitted <==

19

Mannitol respiratory business (Bronchitol® and Aridol®)

Transformational impact of FDA Bronchitol approval (Oct 2020) – business segment cash flow positive from FY 2021 onwards

Sales

  • Bronchitol > 75% of sales

  • Strong short term growth from Russia

  • Sales growth expected in approved markets as patients access hospitals again post COVID-19 restrictions

  • Strong longer term growth contribution expected from US

Expenses

  • Relatively fixed production cost base Potential for simplified business model to reduce costs

Segment EBITDA

  • Forecast ongoing positive EBITDA US volumes contribute to mannitol segment generating profit

==> picture [305 x 353] intentionally omitted <==

Bronchitol in US

  • US CF market >65% of global market in value

US market doubles global cystic fibrosis patient opportunity with attractive pricing

  • Chiesi approval /launch milestone payments US$10m received FY 2021

  • US sales commenced in Q2 CY 2021 – delay in patient initiation due to COVID

  • High teens % of Chiesi sales + 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

==> picture [960 x 51] intentionally omitted <==

----- Start of picture text -----

20
----- End of picture text -----

Board

Significant international pharmaceutical experience

==> picture [74 x 104] intentionally omitted <==

==> picture [71 x 111] intentionally omitted <==

==> picture [74 x 93] intentionally omitted <==

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

  • 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

==> picture [73 x 94] intentionally omitted <==

==> picture [73 x 102] intentionally omitted <==

Gary Phillips – Chief Executive Officer

  • 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

==> picture [5 x 4] intentionally omitted <==

----- Start of picture text -----


----- End of picture text -----

Read more on the Pharmaxis website

Financials

Income statement highlights

Periods ended (A$’000) Sept 2021
Qtr
Sept 2020
Qtr
June 2021
FY
June 2020
FY
Segment Financials
New drug development
Oral LOX (external costs) (1,467) (777) (2,521) (3,124)
Otherprogram external costs(net ofgrants) (303) (297) (1,850) (3,315)
Employee costs (715) (924) (3,270) (3,373)
Overhead (102) (93) (395) (460)
R&Dtax credit - 148 148 5,159
EBITDA (2,587) (1,943) (7,888) (5,113)
Mannitol respiratory business
Sales 3,272 661 6,680 7,027
Other revenue and income 2,342 142 15,985 20
5,614 803 22,665 7,047
Expenses – employee costs (1,197) (1,385) (5,558) (5,855)
Expenses–manufacturing purchases (1,205) (71) (1,168) (1,456)
Expenses–other (1,103) (1,212) (4,483) (3,713)
EBITDA 2,109 (1,865) 11,456 (3,977)
Corporate– EBITDA (755) (860) (3,795) (2,990)
Total Adjusted EBITDA (1,233) (4,668) ($227) ($12,080)
Net profit (loss) (3,179) (4,981) ($2,970) ($13,943)

Financials

Cash

Periods ended (A$’000) Sept 2021
Qtr
Sept 2020
Qtr
June 2021
FY
June 2020
FY
Cash
Cashperiod end 16,131 9,656 18,712 14,764
Cash Flow Statement Highlights
Operations
Receipts from customers 1,156 1,934 7,242 7,775
R&D tax incentive - - 5,433 6,271
Chiesi milestone - - 13,845 -
Sale of distribution rights 2,342 - 1,365 -
Payments to suppliers, employees etc
(net)
(5,443) (6,300) (24,813) (27,330)
Total operations (1,945) (4,366) 3,072 (13,284)
Investing (capex &patents) (40) (100) (644) (574)
Finance leasepayments1 (593) (574) (2,305) (2,232)
Financingagreementpayments2 (3) (68) (240) (270)
Share issue - net - - 4,065 -
Net increase(decrease)in cash ($2,581) ($5,108) $3,948 ($16,360)
  1. Lease over 20 Rodborough Rd (to May 2024) – total liability at 30 June 2021: $6.3 million

  2. NovaQuest financing – not repayable other than as % of US & EU Bronchitol revenue – up to 7 years

==> picture [960 x 51] intentionally omitted <==

----- Start of picture text -----

Refer to Quarterly Shareholder Updates and 2021 Annual Report for additional financial information 23
----- End of picture text -----

Important Notice and Disclaimer

The following notice and disclaimer applies to this investor presentation (Presentation) and you are therefore advised to read this carefully before making any other use of this Presentation or any information contained in this Presentation. By accepting this Presentation you agree to be bound by the limitations, contained within it.

This Presentation has been prepared by Pharmaxis Ltd (ACN 082 811 630) (Company) in connection with the Company’s proposed placement to institution and professional investors (Placement) of new fully paid ordinary shares (New Shares).

==> picture [960 x 51] intentionally omitted <==

----- Start of picture text -----

24
----- End of picture text -----

Important Notice and Disclaimer

NOT AN OFFER

This Presentation is not a prospectus, product disclosure statement, disclosure document or other offering document under Australian law (and will not be lodged with the Australian Securities and Investments Commission (ASIC) or any other law. This presentation is for information purposes only and is not an offer or an invitation to acquire New Shares, securities or any other financial products in any jurisdiction in which, or to any person to whom, it would be unlawful to make such an offer or invitation. This Presentation does not form any part of any contract for the acquisition of New Shares.

This Presentation may not be distributed or released in the United States. This Presentation does not constitute an offer to sell, or the solicitation of an offer to buy, any securities in the United States. The New Shares to be offered and sold under the Offer have not been, and will not be, registered under the U.S. Securities Act of 1933 (the U.S. Securities Act) or the securities laws of any state or other jurisdiction of the United States. Accordingly, the New Shares may not be offered or sold, directly or indirectly, to any person in the United States, except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the U.S. Securities Act and any other applicable U.S. state securities laws.

By accepting this Presentation, you represent and warrant that you are entitled to receive such Presentation in accordance with the above restrictions and agree to be bound by the limitations contained herein.

The distribution of this Presentation (including an electronic copy) may be restricted by law in certain other countries. You should read the important information set out in the ‘Foreign selling restrictions' section to this Presentation. Failure to comply with these restrictions may constitute a violation of applicable securities laws.

Each recipient of this presentation should make their own enquiries and investigations regarding all information included in this presentation including the assumptions, uncertainties and contingencies which may affect the Company’s future operations and the values and the impact that future outcomes may have on the Company.

==> picture [960 x 51] intentionally omitted <==

----- Start of picture text -----

25
----- End of picture text -----

Important Notice and Disclaimer

NOT FINANCIAL PRODUCT ADVICE

This Presentation is for information purposes only and is not financial product advice or investment advice, nor a recommendation to acquire New Shares and has been prepared without taking into account the objectives, financial situation and needs of individuals. Before making an investment decision, prospective investors should consider the appropriateness of the information having regard to their own objectives, financial situation and needs and seek appropriate advice, including financial, legal and taxation advice appropriate to their jurisdiction. The Company is not licensed to provide financial product advice in respect of the New Shares.

SUMMARY INFORMATION

This Presentation contains summary information about the Company and its activities which is current only as at the date of this Presentation (unless otherwise stated). The information in this Presentation is of a general nature and does not purport to be complete nor does it contain all the information which a prospective investor may require in evaluating a possible investment in the Company or that would be required to be included in a prospectus or product disclosure statement prepared in accordance with the requirements of the Corporations Act. In particular, the Company’s business is subject to a number of risk factors both specific to its business and of a general nature. The Company’s business, financial condition and results of operations could be materially and adversely affected by the occurrence of any of the risks associated with its business. The Company’s historical information in this Presentation is, or is based upon, information that has been released to the Australian Securities Exchange (ASX). This Presentation should be read in conjunction with the Company’s other periodic and continuous disclosure announcements lodged with the ASX, which are available at www.asx.com.au. Recipient’s should carefully consider this information in light of their own investment objectives and financial circumstances and should seek professional advice from their stockbroker, solicitor, accountant, or other qualified professional advisor.

==> picture [960 x 51] intentionally omitted <==

----- Start of picture text -----

26
----- End of picture text -----

Important Notice and Disclaimer

PAST PERFORMANCE

Past performance and pro forma historical financial information in this Presentation is given for illustrative purposes only and is not an indication of future performance, including future share price information.

FINANCIAL DATA

All dollar values are in Australian dollars ($ or AUD) unless stated otherwise. Investors should note that this Presentation includes both audited and unaudited financial information for various periods. Information that has not been audited is based on management estimates and not on financial statements prepared in accordance with applicable statutory requirements. Accordingly, recipients should treat this information with appropriate caution.

Investors should also be aware that certain financial data included in this Presentation may be ‘non-IFRS financial information’ under Regulatory Guide 230 Disclosing non-IFRS financial information published by the Australian Securities and Investments Commission or ‘non-GAAP financial measures’ under Regulation G of the US Securities Exchange Act of 1934. The non-IFRS financial information and these non-GAAP financial measures do not have a standardised meaning prescribed by AIFRS and, therefore, may not be comparable to similarly titled measures presented by other entities, nor should they be construed as an alternative to other financial measures determined in accordance with AIFRS. Investors are cautioned, therefore, not to place undue reliance on any non-IFRS financial measures included in this Presentation.

==> picture [960 x 51] intentionally omitted <==

----- Start of picture text -----

27
----- End of picture text -----

Important Notice and Disclaimer

DISCLAIMER

No party other than the Company has authorised or caused the issue, lodgement, submission, dispatch or provision of this Presentation, or takes any responsibility for, or makes or purports to make any statements, representations or undertakings in this Presentation. No person is authorised to give any information or make any representation in connection with the Placement which is not contained in this Presentation. Any information or representation not contained in this Presentation may not be relied upon as having been authorised by the Company in connection with the Placement. While the information in this Presentation has been prepared in good faith and with reasonable care, no representation or warranty, express or implied, is made as to the accuracy, adequacy or reliability of any statements, estimate, opinions or other information contained in the Presentation.

To the maximum extent permitted by law, the Company and its advisers, related bodies corporate, directors, officers, employees, representatives and agents:

• exclude and disclaim all liability (including, without limitation, any liability arising from fault, negligence or negligent misstatement) for any direct or indirect expenses, losses, damages or costs incurred as a result of participation in the Placement or the information in this Presentation being inaccurate or incomplete in any way for any reason;

  • disclaim any obligations or undertaking to release any updates or revision to the information in this Presentation to reflect any change in expectations or assumptions; and

• make no representation or warranty, express or implied, as to the currency, accuracy, reliability or completeness of information in this Presentation and take no responsibility for any part of this Presentation or that this Presentation contains all material information about the Company or that a prospective investor or purchaser may require in evaluating a possible investment in the Company or acquisition of shares in the Company, or likelihood of fulfilment of any forward-looking statement or any event or results expressed or implied in any forward-looking statement.

==> picture [960 x 51] intentionally omitted <==

----- Start of picture text -----

28
----- End of picture text -----

Important Notice and Disclaimer

FOREIGN SELLING RESTRICTIONS

This document does not constitute an offer of new ordinary shares (New Shares) of the Company in any jurisdiction in which it would be unlawful. In particular, this document may not be distributed to any person, and the New Shares may not be offered or sold, in any country outside Australia except to the extent permitted below.

Hong Kong

The contents of this document have not been reviewed or approved by any regulatory authority in Hong Kong. The information in this document has not been, and will not be, registered as a prospectus in Hong Kong under the Companies Ordinance (Cap 32) (CO) nor has it been authorised by the Securities and Futures Commission (SFC) in Hong Kong pursuant to the Securities and Futures Ordinance (Cap 571) of the Laws of Hong Kong (SFO). Accordingly, the document must not be issued, circulated or distributed in Hong Kong other than:

(i) to “professional investors” within the meaning of SFO and any rules made under that ordinance (HK Professional Investors); or

(ii) in other circumstances which do not result in the information in this presentation being a “prospectus” as defined in the CO nor constitute an offer to the public which requires authorisation by the SFC under the SFO.

Unless permitted by the securities laws of Hong Kong, no person may issue or have in its possession for issue, whether in Hong Kong or elsewhere, any advertisement, invitation or document relating to New Shares, which is directed at, or the content of which is likely to be accessed or read by, the public of Hong Kong other than with respect to New Shares which are or are intended to be disposed of only to persons outside Hong Kong or only to HK Professional Investors. No person allotted New Shares may sell, or offer to sell, such New Shares to the public in Hong Kong within six months following the date of issue of such New Shares. This offering is not an offer for sale to the public in Hong Kong and it is not the intention of the Company that the New Shares be offered for sale to the public in Hong Kong.

United States

This document may not be distributed or released in the United States.

This document does not constitute an offer to sell, or a solicitation of an offer to buy, any securities in the United States or any other jurisdiction in which such an offer would be illegal.

The New Shares have not been, and will not be, registered under the U.S. Securities Act or the securities laws of any state or other jurisdiction of the United States. Accordingly, the New Shares may not be offered or sold directly or indirectly in the United States, unless they have been registered under the U.S. Securities Act (which the Company has no obligation to do or procure) or they are offered and sold in a transaction exempt from, or not subject to, the registration requirements of the U.S. Securities Act and any other applicable U.S. state securities law.

==> picture [960 x 51] intentionally omitted <==

----- Start of picture text -----

29
----- End of picture text -----