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.

ACRUX LIMITED Investor Presentation 2021

Sep 1, 2021

64293_rns_2021-09-01_bf84f627-3b76-466f-885b-a72505895aac.pdf

Investor Presentation

Open in viewer

Opens in your device viewer

==> picture [164 x 83] intentionally omitted <==

ACRUX INVESTOR PRESENTATION (ASX: ACR)

September 2021

==> picture [92 x 540] intentionally omitted <==

IMPORTANT NOTICE AND DISCLAIMERS

This presentation contains forward-looking statements which are identified by words such as ‘may’, ‘could’, ‘believes’, ‘estimates’, ‘expects’, or ‘intends’ and other similar words that involve risks and uncertainties.

These statements are based on an assessment of present economic and operating conditions, and on a number of assumptions regarding future events and actions that, as at the date of this presentation, are expected to take place.

Actual results could differ materially depending on factors such as the availability of resources, the results of non-clinical and clinical studies, the timing and effects of regulatory actions, the strength of competition, the outcome of legal proceedings and the effectiveness of patent protection.

Such forward-looking statements are not guarantees of future performance and involve known and unknown risks, uncertainties, assumptions and other important factors, many of which are beyond the control of our Company, the Directors and our management.

We cannot and do not give any assurance that the results, performance or achievements expressed or implied by the forward-looking statements contained in this presentation will actually occur and investors are cautioned not to place undue reliance on these forwardlooking statements.

We have no intention to update or revise forward-looking statements, or to publish prospective financial information in the future, regardless of whether new information, future events or any other factors affect the information contained in this presentation, except where required by law and under our continuous disclosure obligations.

These forward looking statements are subject to various risk factors that could cause our actual results to differ materially from the results expressed or anticipated in these statements.

==> picture [66 x 55] intentionally omitted <==

2

==> picture [211 x 540] intentionally omitted <==

==> picture [59 x 59] intentionally omitted <==

==> picture [59 x 59] intentionally omitted <==

==> picture [59 x 59] intentionally omitted <==

Acrux has a demonstrated track record of development and commercialisation of topical prescription pharmaceuticals Acrux has growing revenue from its product portfolio including revenue share, profit share and milestones Acrux has 3 products sold globally with a pipeline of 12 products in various stages of development and 6 commercial partnerships in place

==> picture [66 x 55] intentionally omitted <==

==> picture [92 x 540] intentionally omitted <==

==> picture [44 x 43] intentionally omitted <==

Business overview

Acrux has a demonstrated track record of development and commercialisation of topical prescription pharmaceuticals

Acrux product history

Past Acrux outcomes

Testosterone solution  The product generated substantial Was sold in 6 countries with revenue share returns for Acrux shareholders through and milestones received by Acrux from payment of milestones and revenue FY10 – FY18. share to the Company Products commercialised by Acrux Acrux currently marketed products Recent Acrux outcomes Estradiol spray Currently sold as Evamist® in the United  Acrux revenue from its Estradiol States. licensees grew 25% in FY21 over prior financial year Currently sold as Lenzetto® in over 30 countries with milestones and revenue  Revenue share payable to Acrux share received by Acrux from FY17 onwards. exceeded $1 million in FY21

==> picture [66 x 55] intentionally omitted <==

4

==> picture [92 x 540] intentionally omitted <==

==> picture [44 x 43] intentionally omitted <==

Business overview

Acrux has growing revenue from its product portfolio including revenue share, profit share and milestones

Acrux has 3 products sold globally with a pipeline of more than 12 products in various stages of development and 6 commercial partnerships in place

  • Acrux product pipeline

  • As at end August 2021 Acrux has 15 products in its generic topical portfolio  3 products FDA approved in 2021

  • Product including one commercialised in August pipeline 2021  12 products under various stages of development by Acrux including 2 products under FDA review

  • Recent Acrux outcomes

  • FDA approval received for 3 products in 2021 to date

  • Acrux licensee launched generic Testosterone Topical Solution in August 2021

  • 6 commercial agreements for 11 products including 4 agreements executed since 2020 for 9 products

==> picture [66 x 55] intentionally omitted <==

5

==> picture [92 x 540] intentionally omitted <==

==> picture [40 x 39] intentionally omitted <==

Key Investment highlights

 3 products on market in over 30 countries including Testosterone Topical solution launched in August 2021 in the United States Focus on specialised15 topical generic products in portfolio including 12 in various stages of and lucrative topical development with an addressable market of ~US$1.2bn[1] generic market  The topical generic market provides attractive returns with low-risk and low development costs for highly specialised drug developers  The size of the topical generic market in the US is ~US$16bn[2]

==> picture [867 x 311] intentionally omitted <==

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

 Proven commercialisation strategy to bring a portfolio of products to market
 Led by an experienced management team, Acrux possesses unique development and
Highly skilled commercialisation know-how and capabilities

development team TGA approved, Good Manufacturing Practice (GMP) facility with 25 specialised
scientists creates a substantial competitive advantage in generic product selection,
development and commercialisation
 Products sold through licensees in Europe, the United States and other countries
R&D investment in 
FDA approvals received for Prilocaine/Lidocaine cream 2.5%/2.5% and Efinaconazole
product pipeline solution 10% in mid 2021

entering 6 commercial agreements with 6 different pharma companies for 11 products in
commercialisation place. Licensing agreements feature recurring revenue on commercialisation
 Objective to be cash flow positive by end of 2022
6 1. IQVIA Q2, 2021 MAT, US market sales (US$) 2. US market sales by dosage form, IQVIA Q3, 2020 MAT, (US$)
----- End of picture text -----

==> picture [92 x 540] intentionally omitted <==

==> picture [44 x 44] intentionally omitted <==

Acrux is focussed on an underserved market segment

Total market Oral drugs Acrux focus:
Prescription topical drugs
Definition of market
(all drugs including NCEs
and generics)

Total US prescription
pharma market

Drugs that are
ingested orally
(eg tablets, capsules)
Drugs that are applied topically to the
skin, eyes, ears and nose
(egcreams,ointments, gels,solutions)
Market size1 >US$520bn ~US$200bn ~US$16bn2
Generic market share ~90%3 ~91%3 47%4
Typical generic
development
complexity
Variable Low Greater complexity than
oral generic drug development
Generic competition Variable High competition
from many generic
drug manufacturers
Limited generic competition
given niche market and
development complexity

Source:

  1. US market by dosage form, IQVIA Q3, 2020 MAT, US market sales (US$); 2. Market size for topically applied drugs IQVIA Q3, 2020 MAT, US market sales (US$)

  2. IQVIA Global Generic and Biosimilars Trends and Insights – 2018; 4. IQVIA, National Sales Perspectives, January 2019 – Unbranded generic share of dermatology, MAT

==> picture [66 x 55] intentionally omitted <==

7

==> picture [92 x 540] intentionally omitted <==

==> picture [37 x 37] intentionally omitted <==

Revenue generating business model supporting long-term growth

==> picture [438 x 310] intentionally omitted <==

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

1 2
Product
Generic drug development
identification and technology
transfer to CMO
4 3
Product launch
and profit share FDA submission,
revenue from review
commercial and approval
marketing partners
----- End of picture text -----

  • On market products are generating growing revenues for Acrux from growth of existing products and new launches

  • Through the Acrux GMP facility with 25 specialised scientists, Acrux possesses the capabilities to develop and commercialise generic topical and transdermal pharmaceutical products

  • The core business model of generic drug development is supported by ongoing licensing opportunities for commercial marketing and distribution

==> picture [66 x 55] intentionally omitted <==

8

==> picture [92 x 540] intentionally omitted <==

FY21 Profit and Loss

Profit and loss for the year ended 30 June 2021 Profit and loss for the year ended 30 June 2021
2021
2020
Movement
Movement
$’000
$’000
$’000
%
Revenue and Other Income
Revenue from licensing agreements
R&D Tax Incentive Rebate
Other income
Total Revenue and Other Income
Less: Expenses
External R&D Expenses
Salaries and Directors' Fees
Depreciation and amortisation
Other Expenses
Total Expenses
Loss before income tax
Income tax benefit/(expense)
1,337
1,253
84
7%
3,421
2,327
1,094
47%
398
365
33
9%
5,156
3,945
1,211
31%
8,928
5,012
3,916
78%
6,109
5,712
397
7%
664
707
(43)
-6%
1,887
1,899
(12)
-1%
17,588
13,330
4,258
32%
(12,432)
(9,385)
(3,047)
32%
(197)
(86)
(111)
129%
Net loss for theyear (12,629)
(9,471)
(3,158)
33%
Basic loss per share (cents)
Cash reserves
(5.75)
(5.65)
(0.10)
-2%
15,270
9,206
6,064
66%

==> picture [66 x 55] intentionally omitted <==

9

==> picture [92 x 540] intentionally omitted <==

FY21 Cashflow

==> picture [692 x 476] intentionally omitted <==

==> picture [66 x 55] intentionally omitted <==

10

==> picture [92 x 540] intentionally omitted <==

==> picture [65 x 65] intentionally omitted <==

BENEFITS OF A POOLED DEVELOPMENT FUND

1 Companies with PDF status are taxed at 15% on their income and capital gains received from their investments 2

Australian resident shareholders are exempt from capital gains tax after selling their shares

3

Unfranked dividends received by an Australian resident shareholder from the Company will be exempt from tax in the hands of the shareholder 4

Franked dividends will also be exempt from tax unless the shareholder elects to treat the franked dividend as taxable

Shareholders should seek professional advice from their tax advisor regarding Pooled Development Funds and the benefits specifically available to their situation

==> picture [66 x 55] intentionally omitted <==

11

==> picture [211 x 540] intentionally omitted <==

Acrux Investment Opportunity

==> picture [59 x 375] intentionally omitted <==

Track record of developing and launching products Increasing revenue from marketed products Extensive product pipeline under development FDA approval of 3 products in 2021 Additional product launches planned in 2022 Strong management team

==> picture [66 x 55] intentionally omitted <==

==> picture [211 x 540] intentionally omitted <==

Thank you

Michael Kotsanis

CEO & Managing Director Acrux Limited

P: + 61 3 8379 0100 E: [email protected]

Visit our website: http://www.acrux.com.au/ Follow us on LinkedIn:

==> picture [47 x 47] intentionally omitted <==

==> picture [66 x 55] intentionally omitted <==