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CLINUVEL PHARMACEUTICALS LIMITED Management Reports 2021

Jan 24, 2021

64726_rns_2021-01-24_224568f2-1e6f-4136-9b6e-63ec49411dec.pdf

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We have entered a new year, one brimmed with optimism and hanging our hopes on the reversal of global health and the restart of our economies

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On the historical day of 20 January, we record the anniversary of the first COVID case reported in South Korea

COVID Update

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I also postulate that the current vaccination programs will rapidly exert their effects in Europe – and in the future, in developing nations across the world

Creeping Inflation and Impact on

Pharmaceuticals

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Central banks are continuing to inject liquidity in the markets, while credit to small businesses and households is slowing down in the EU

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CLINUVEL’s Year Ahead

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By design, the Group has been strengthened to diversify its activities

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US-EU-AU Distribution

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In Q4 2020, a landmark event has been the approval of code J7352 for SCENESSE®

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The commercial status quo on 1 January 2021 is that SCENESSE® is now listed at a uniform price across all US states, with a designated J-code

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DNA Regeneration Program

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We are analysing the DNA reparative properties in melanocortins in man

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Single-strand DNA damage is a well-known phenomenon occurring in all of us following UV exposure

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Stroke Program

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CLINUVEL’s stroke program focuses on ischaemic stroke, responsible for 85-87% of all stroke cases, which arise from physical obstruction of blood vessels. For an indepth look at the vascular system, see Scientific Communique VII

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PRÉNUMBRA®

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Differences in Afamelanotide Formulations
SCENESSE®
PRÉNUMBRA®
Key pharmaceutical
ingredient
Afamelanotide
Afamelanotide
Polymers
Yes
Yes
Injectable
Yes
Yes
Route of
administration
Subcutaneous
Subcutaneous
Dissolvable
Yes
Yes
Removable
Yes
No
Dosing
Fixed
Flexible
Patients
Adults
Adults
Administration
Byaphysician
Byaphysician
Self-injectable
No
No
Category
Chronic, EPP
Acute, life
threatening
Toxicologyknown
Yes
Yes
Differences in Afamelanotide Formulations
SCENESSE®
PRÉNUMBRA®
Key pharmaceutical
ingredient
Afamelanotide
Afamelanotide
Polymers
Yes
Yes
Injectable
Yes
Yes
Route of
administration
Subcutaneous
Subcutaneous
Dissolvable
Yes
Yes
Removable
Yes
No
Dosing
Fixed
Flexible
Patients
Adults
Adults
Administration
Byaphysician
Byaphysician
Self-injectable
No
No
Category
Chronic, EPP
Acute, life
threatening
Toxicologyknown
Yes
Yes
Differences in Afamelanotide Formulations
SCENESSE®
PRÉNUMBRA®
Key pharmaceutical
ingredient
Afamelanotide
Afamelanotide
Polymers
Yes
Yes
Injectable
Yes
Yes
Route of
administration
Subcutaneous
Subcutaneous
Dissolvable
Yes
Yes
Removable
Yes
No
Dosing
Fixed
Flexible
Patients
Adults
Adults
Administration
Byaphysician
Byaphysician
Self-injectable
No
No
Category
Chronic, EPP
Acute, life
threatening
Toxicologyknown
Yes
Yes
Differences in Afamelanotide Formulations
SCENESSE® PRÉNUMBRA®
Key pharmaceutical
ingredient
Afamelanotide Afamelanotide
Polymers Yes Yes
Injectable Yes Yes
Route of
administration
Subcutaneous Subcutaneous
Dissolvable Yes Yes
Removable Yes No
Dosing Fixed Flexible
Patients Adults Adults
Administration Byaphysician Byaphysician
Self-injectable No No
Category Chronic, EPP Acute, life
threatening
Toxicologyknown Yes Yes

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Human Resources

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The intrinsic value of the Company is encapsulated largely by its staff.

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13

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Public and Investor Relations

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H.C. Wainwright Bioconnect was an early opportunity to gauge how well CLINUVEL is positioned to diversify and grow.

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14

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

30.00 12
10
25.00 8
6
20.00 4
2
15.00 0
Share Price, A$ Close (LHS) Aggregate Shorts, % of Issued Shares (RHS)
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Conclusion

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15

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

$45,000 $350,000
$40,000
$300,000
$35,000
$250,000
$30,000
$25,000 $200,000
$20,000 $150,000
$15,000
$100,000
$10,000
$50,000
$5,000
$0 $0
06 07 08 09 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24
Financial Year A$ Cash Used
Cumul. Expend.
Cash Used A$'000
Cumulative Expenditure A$'000
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16

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In 2021 we strive and expect to outshine previous years as we build out the group of companies.

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17

Share price

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ASX: CUV 22 January 2018 – 22 January 2021
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----- Start of picture text -----

$45 49,410,338
49,548,671
$40
A$1.07bn
$35
$30
$25
$20
$15
$10
$5
22-Jan-18 22-Jul-18 22-Jan-19 22-Jul-19 22-Jan-20 22-Jul-20 22-Jan-21
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Contact

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