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10/06CLINUVEL PHARMACEUTICALS : Operations Update Webcast II
10/05Australia shares nearly flat as financials' losses offset tech, healthcare gains
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Clinuvel Pharmaceuticals : Investor Webinar Financial Results

08/26/2021 | 08:51pm EDT


CLINUVEL Investor Webinar

Financial Results Year Ended

30 June 2021



Melbourne, Australia, 27 August 2021





CLINUVEL PHARMACEUTICALS LTD held an investor and analyst webinar on the financial results for the year ended 30 June 2021 at 18:00 AEST on 26 August 2021. The webinar discussion is set out below:


Mr Bull: Welcome to everyone joining us today for this briefing on the financial results of CLINUVEL PHARMACEUTICALS LTD for the financial year ending 30 June 2021. I am Malcolm Bull, Head of Investor Relations for CLINUVEL. Joining me to discuss the results is Dr Philippe Wolgen, Managing Director and Mr Darren Keamy, Chief Financial Officer. Welcome Philippe and Darren.

Mr Keamy: Hi Malcolm and greetings to everyone on the line.

Dr Wolgen: Good to be with you.

Mr Bull: We're streaming this webinar at six in the evening in Melbourne so European investors can dial in at the start of their business day, noting it is very early morning for US attendees.

The format of today's webinar is to ask Darren as CFO to provide details of the results for the year ending 30 June 2021, and I will also invite Dr Wolgen to comment on the results from a MD's operational and strategic viewpoint.

We have received a number of questions from shareholders and analysts which are covered in this webinar and, although questions may still be posted during the webinar, we may not be able to address them all in the time we have today.

Please note, the FY2021 results were posted 8 hours ago to the Australian Securities Exchange, with News Communiqué IV and a general corporate presentation. CLINUVEL has received a number of requests for press interviews, and our Managing Director has presented today to TV and print media, and will address the German speaking shareholders on Friday via a YouTube interview. Finally, note that all figures mentioned and reported are in Australian dollars, and attendees are advised to refer to the Appendix 4E Preliminary Financial Report on our website for more detail.

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CLINUVEL Investor Webinar, FY2021 Results


Mr Bull: Without further ado, Mr Keamy, Darren, can you first provide a summary of the results as announced to the ASX earlier today?

Mr Keamy: Yes, it is my pleasure. We start off with the headline revenues, expenses, and profit figures. In the 2021 financial year, the CLINUVEL Group achieved record annual revenues of $48.451 million. This is a 43% increase compared to the 2020 financial year. At $22.738 million, expenses were relatively constant with an increase of only 2% to the previous year. Net profit before tax was also a record $25.713 million and the after tax profit result was $24.728 million - another high for CLINUVEL.

Mr Bull: Thanks Darren. Before we delve into the results, the audience today may like to know how you interpret these results as the longstanding CFO of the Company?

Mr Keamy: Overall, it is an excellent result. FY2021 is the fifth consecutive year of positive cash flow and profit since we commenced commercial operations in June 2016 in Europe following the marketing authorisation granted by the European Medicines Agency. It also marks the first full year of commercial operations in the USA, which have made a meaningful contribution to this year's result. It is extremely satisfying to have been a part of a growth story in CLINUVEL where the journey has taken me through the research and development phase to commercialisation of SCENESSE® and now, to be working on the growth of commercial operations and the expansion of the research and development program to treat other patient groups and to develop new products.

Mr Bull: I agree with you that these are excellent results and should fill all stakeholders of CLINUVEL with pride. I now wish to invite our Managing Director, Dr Philippe Wolgen to comment on the results for FY2021.

Dr Wolgen: Thank you Mr Bull, Mr Keamy, not only for your commentary today but for the work done the past year.

CLINUVEL's 2021 performance asks for a fundamental discussion of its operations and underlying business model.

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CLINUVEL Investor Webinar, FY2021 Results

Therefore, starting with the financial year 2021, we have aggressively increased our staff working from seven countries and four continents to ensure we better control distribution and market access and grow the Group's research, development, and innovation capabilities. In doing so, we continued to invest, while we controlled our overall expenses with a 2% increase to A$22.7 million. In accounting for the direct and indirect costs, we reinvested more than 40% of our revenues to enable further organic growth.

In keeping with our mission to select, train and accredit prescribing centres and monitor physicians and patients longitudinally, we continued direct distribution to all hospitals and specialised medical centres within the European Economic Area and United States. Despite the various viral peaks and variants paralysing societies in Europe and the US, we managed to grow the number of accredited centres, number of patients and number of SCENESSE® administrations. In the US, our team managed to secure novel treatment codes, facilitating automatic processing by insurers to allow the hormonal treatment to reach porphyria patients faster.

As a result of making these resources available at times when the world was constricting, we actually grew total revenues by 43% yielding a PBIT which increased by 123% to A$25.7 million.

I am generally more interested in the long-range effects of our strategic measures, not just 12-month results. I want us to keep in mind a longer horizon. Therefore, we zoomed in on the compounded annual growth rate since 2016, with a CAGR of 46% the past 12 months. The solid trend in revenues the past five years needs a note to FY2020, since a percentage of the orders and payments occurred prior to the book year 2020. So, in all, we witness a linear compounded growth for five consecutive years with a double-digit expansion rate.

As you see in the graph, the orientation of expenditures reflects our gradual and controlled increase in research, development, and innovation. As our shareholders are used to from us, expenditures have been scrupulously controlled, and the financial management of capital has largely contributed to the strong balance sheet of the Group we enjoy today to withstand cyclicality in markets.

Our expenditures have grown year on year but levelled off from FY2020 in FY2021.

Taking these considerations further, we now zero in on net profits after income tax as found over the last five years.

Page 3 of 9

CLINUVEL Investor Webinar, FY2021 Results

Again, here one sees double digit increases each year and for FY2021, a CAGR of 51% in net profits over FY2020.

As alluded to moments ago, we chose in 2014 a distinct commercial approach which would provide CLINUVEL a competitive advantage, yet not habitual in the pharmaceutical sector, and certainly a less familiar path for ASX- listed pharmaceutical companies: we established our own teams in the EEA & US to execute a formal hospital- monitoring program providing essential long-term safety data and measures of efficacy. Staying with the same anthem, we instituted a market access and distribution team to directly engage with insurers on both sides of the Atlantic.

For the new attendees and shareholders today, in 2014 we judged three corporate options whether to:

  1. sell CLINUVEL to a larger pharma company;
  1. enter a license agreement to distribute SCENESSE®; or
  1. integrate all commercial functions and go ourselves.

Today's glowing results not only fortify once more the linear trajectory of CLINUVEL, but the numbers directly correlate with the risk analyses we made in 2014 and the decision we made as a Board to set up EU and US operations ourselves. This very decision has greatly benefited patients and their families, and the overwhelming majority of CLINUVEL's shareholders. At this point in time, I must publicly acknowledge all my staff and the Board, all the cogs - small and large - who have made the CLINUVEL timepiece tick with precision and constancy, while putting this performance against the most challenging operational and economic conditions.

These results provide a foundation for more activities, further expansion, organically and inorganically.

Mr Bull: Thank you Dr Wolgen. Mr Keamy, you commented in the past on the sustainability of the business - can you give us your thoughts on this topic?

Mr Keamy: As I previously mentioned, we have just posted our fifth consecutive profit, and our cash reserves have increased to a level that should be sufficient to self-finance our planned expansion. This indicates fiscal sustainability, but it's not just about what we have achieved financially. It's also how we have evolved the business processes to achieve long term sustainability. We strive to be able to independently operate without

Page 4 of 9

CLINUVEL Investor Webinar, FY2021 Results

risk of insolvency. We have come a long way since when I first joined the Company when we had around two quarters of cash in the bank, so we feel well placed to serve our patients and stakeholders.

We are committed to grow the commercial part of the business and translate our pharmaceutical technology to other indications and also wider populations who have an unaddressed need of protection and DNA Repair. These are potentially larger markets than the existing pharmaceutical business based on the treatment of EPP patients. So, we are working in parallel on long term growth to progress our recent track record into many more years of positive performance.

Mr Bull: Let's now delve into the results, starting with revenues. What has driven the significant rise in revenues?

Mr Keamy: I'll cover Europe first, then the USA.

In Europe, revenues were impacted in the second half of the previous financial year by the initial COVID-19 wave that spread across the continent. During the 2021 financial year we saw patients who had found it difficult to get treatment return to Expert Centres and new patients also receive treatment. Overall, there was a rise in revenues in the European Economic Area although its impact was constrained by the conversion of Euro revenues to our Australian dollar reporting currency which strengthened during the financial year.

In the USA, we commenced commercial operations in April 2020, which provided only initial orders in the FY2020 result. The completed financial year 2021 is therefore a good measure how we enter a new continent, implementing a system to run our US commercial operations.

We have experienced strong physician's willingness to prescribe the new treatment, and training and accreditation required much of our resources and time. We expanded the number of Specialty Centers throughout the US, and the insurances needed to be engaged in each state with their own rules and regulations. As Dr Wolgen stated, we secured novel treatment codes for a prescriptive treatment which had not existed before for these insurers, so we needed to educate each and every insurer in all US states. In general, there is a lot of red tape to go through to get a new treatment on an insurers' list. We did well and obtained faster Prior Authorization status from individual insurers than what we did in FY2020. This resulted in faster turnaround times, less travel time and faster booking of appointments by patients.

In addition, our team in the US, led by Dr Linda Teng has done an outstanding job in distributing and assisting insurers and patients, the same way Mrs Colucci, Dr Hamila and Mr Hay have accomplished in Europe.

The US team have trained and accredited over 40 centres compared to our plan of 30 by the end of 2021 and we have over 60 national and state based private insurers reimbursing the cost of treatment under Prior Authorization. Some of our US patients have now experienced year-round treatment. This reflects a willingness, from patients to continue treatment and it demonstrates the value our drug provides to our patients.

Finally, in 2021, we entered a new region, the Middle East, by obtaining a breakthrough in Israel, the right to distribute SCENESSE® to patients who live all year around in an isolated state due to the intensity of light and intense heat.

Mr Bull: Let's dig into the US roll out a little further. Can you provide more information on US cash receipts, as well as the receipt cycle in Europe compared to the US?

Mr Keamy: In the US, based on our experiences so far, cash receipts are expected to be less seasonal since the approval of the FDA allows treatment every 60 days and thus treatment may be provided all year round. This means for the same number of patients the frequency of treatments provided can be higher in some states all year around compared to Europe, and cash receipts would follow this trend. Furthermore, the cash receipt cycle in Europe is fairly short with payment being made to CLINUVEL in around 30 to 60 days from placement of order. In the US, the cycle seems longer. With the new and unique treatment codes, this period may well reduce.

Mr Bull: A shareholder has asked: what is the pricing policy of the Company?

Mr Keamy: We operate a uniform net price for SCENESSE® per continent, reflecting our frequent communication on this topic and our values of fairness and equitability to patients, physicians, and insurers. We have two

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CLINUVEL Investor Webinar, FY2021 Results

This is an excerpt of the original content. To continue reading it, access the original document here.


Clinuvel Pharmaceuticals Limited published this content on 27 August 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 27 August 2021 00:50:11 UTC.

© Publicnow 2021
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Philippe Jacques Wolgen Chief Executive Officer, MD & Director
Darren M. Keamy Chief Financial Officer & Secretary
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