TRADE RECEIVABLES
Financial Review
CLINUVEL has delivered another exceptional year of performance, achieving record revenues, the ninth consecutive year of profitability, and a $37 million increase in net assets.
Our consistent financial growth reflects the Company’s disciplined strategy towards year-on-year improvement, supported by the continued advancement of our clinical pipeline, providing a strong financial foundation to sustain, build and expand future revenue streams.
The SCENESSE® program continues to scale, reaching more patients globally through an increased number of qualified and trained treatment centres supported by increased outreach and marketing initiatives to amplify our patient support, market presence and sales. This broader visibility not only supports product uptake but also enhances clinical trial recruitment, particularly for our vitiligo study, paves the way for the upcoming launch of our PhotoCosmetics range, and increased company visibility to investors.
CLINUVEL’s industry presence has been highlighted by our collaboration with global patient and professional foundations supporting communities in vitiligo, porphyria, and rare disorders, which culminated with our major investment in our custom-built Pavilion of Photomedicine at the American Academy of Dermatology Annual Meeting held in Florida in March 2025.
We continue to reinvest in our key strategic assets, namely our people, clinical programs, and infrastructure to build a diversified and sustainable business. In the context of ongoing geopolitical uncertainty, we remain prudent in the deployment of our capital to protect shareholder value while ensuring sufficient resources are delivering projects without reliance on external capital or dilutionary events.
In 2021, our release of our five-year $175 million strategic expenditure plan (excluding CBM costs) was met with skepticism, particularly within the biotechnology sector where long-term predictability is uncommon. However, CLINUVEL has exceeded expectations by delivering its plan with a total spend of $171.2 million, $3.8 million under budget, while consistently delivering year-on-year growth in revenue, profit, and assets.
This achievement reflects a clear strategic vision and high performance of our team, whose ongoing development and success are integral to our culture. At CLINUVEL, our people are our most valuable asset and we’re committed to incentivising, retaining, and nurturing identified talent.
During FY2025, we expanded our teams across operations, clinical development, and communications, branding, and marketing (CBM), ensuring continued alignment and delivery of our growth objectives.
Five-year expenses to 30 June 2025 (A$m)
Revenue Performance
CLINUVEL reported a 10% increase in total revenue (including interest and other income) for FY2025 for our ninth consecutive year of revenue growth.
Since launching SCENESSE® in 2016, the program has achieved a compound annual growth rate (CAGR) of 35%. Over 18,500 SCENESSE® implants administered to EPP patients globally, demonstrating the sustained success and safety of the program.
Commercial sales, including Special Access Scheme reimbursement revenues, increased by 8% to $95 million, contributing to total FY2025 revenue of $105.3 million, up $10 million from FY2024.
Growing venues (A$m)
SCENESSE® Market Expansion
The global growth of SCENESSE® sales was driven by increased patient numbers, more frequent dosing, and the expansion of trained and accredited centres. We are well into the second phase of expanding the number of trained and accredited centres across North America which currently represents 104 centres, supported by over 100 insurers. We remain on track to reach 120 centres by the end of December 2025. Our patient liaison teams continue to play a crucial role in supporting healthcare professionals and patients with treatment access, compliance, distribution logistics, and navigating insurance governmental and private insurer frameworks.
We were also pleased to execute a distribution agreement in January 2025 with Diligens Salud SA, part of the Scienza Group, for SCENESSE® in another new region, Argentina.
Other Income
CLINUVEL strengthened its cash reserves with a $40.2 million increase (22%) in FY2025 reaching a combined $224.1 million in cash and term deposits. Strong yields from its A$ and US$ term deposits generated $9.4 million in interest income, up 29% from the prior year.
In anticipation of the potential decline in interest rate yields, we elected to extend the average maturity length of our term deposits which now have an average of 309 days with a weighted average yield of 4.70%.
Expense Management
In line with our expectations, total expenses for FY2025 increased by $9.1 million (20%) to $53.7 million reflecting the planned investments we outlined that we’d be making across key areas to support strategic expansion. This expansionary expenditure continues to be closely monitored to ensure it has strategic alignment to value creation and shareholder returns.
Personnel Expenses
Increased by $5.9 million (31%) due to headcount growth, particularly across clinical, regulatory, and communications. During the financial year we also bolstered the Board when we welcomed three new Directors each with their own deep intrinsic knowledge and skill in their respective disciplines. Our employee attract, retain, and reward strategy includes developing an individualised career, performance bonus, and equity-based incentive plan tied to strategic organisational targets to drive company-wide success.Materials and Related Expenses
Inclusive of changes in inventories, this item increased by 9% to $4.5 million during FY2025 as our team, primarily at our Singapore RD&I Centre, continue their investigative development works surrounding new formulations and delivery innovations for NEURACTHEL®, PRÉNUMBRA®, ACTH, and our PhotoCosmetics range.Distribution Expenses
Increased by 10% to $4 million primarily being a direct result of our higher SCENESSE® sales volumes throughout our distribution chain. Throughout the year we investigated and implemented operational efficiencies across our global supply and distribution chains, particularly in light of ever-changing geopolitical conditions and lighted our distribution footprint in both Europe and the US.Corporate, Finance & General Expenses
These costs remained tightly controlled with only a marginal increase despite growing business activity. This control is the result of a series of operational, administrative and financial process cost reviews as well as system optimisation and advancements.Legal, Insurance & IP
Decreased 42% to $1 million resulting from a reduced level of legal activity during the year and a thorough review of our insurance programs leading to optimised insurance solutions.Communications, Branding & Marketing (CBM)
CBM expenditure doubled to $4.4 million as expected, as we invested in global brand visibility to attract a wider audience. Shareholders and investors have no doubt witnessed CLINUVEL’s increased presence across numerous platforms including online and print media, complemented by our physical presence at key industry events over the past 12 months. We have also sponsored and supported numerous key industry and global community events hosted by vitiligo, porphyria and other rare disease foundations, as well as supported organisations who perform research in these areas to support those affected by rare disorders. Our key investment in this area was in March this year with our custom-built 4,800 sq ft Pavilion of Photomedicine at the prestigious American Academy of Dermatology Annual Meeting in Florida, U.S.A.. This five-day event was attended by more than 20,000 physicians, clinicians, academics and industry representatives who were all captivated and enthralled by CLINUVEL’s presence and impact at the event. As foreshadowed at the end of the last financial year, CLINUVEL has extended its branding presence to distinguish itself from a traditional pharmaceutical company in translating its core pharmaceuticals technology in melanocortins to PhotoCosmetics, creating synergistic revenue opportunities. Our P-Line PhotoCosmetics range will soon commence a pre-marketing launch phase ahead of a full commercial launch in 2026.Clinical and Non-Clinical Development
In line with our anticipations, our Clinical and non-clinical development expenses increased by $5 million to $7.4 million, representing 215% increase from FY2024. This is intrinsically linked to the advancement of our core programs, most notably our Phase III CUV105 study for treatment of vitiligo which was fully recruited in May 2025. Our increased expenditure also reflects our efforts in other clinical study programs, including the CUV104 Phase II pilot monotherapy study and the CUV803 Phase II stroke study. Formulation and manufacturing development work also continued across our PhotoCosmetics M-lines, “Preserve” and “Bronze” product ranges.Profit Outcomes
For the fiscal year, the Company reported a Net Profit Before Tax of $51.6 million, an increase of $0.87 million (2%), on the prior year. This growth highlights our effective financial stewardship and success in achieving strategic growth objectives whilst maintaining stringent expenditure control.
The Net Profit After Tax of $35.3 million reflects a decrease of $0.35 million (1%) on the prior year. The significant fall in the Australian dollar during the year gave rise to a larger deferred tax position from unrealised gains made on international foreign currencies being translated back into Australian dollars due to an IFRS accounting treatment requirement. Whilst this additional deferred tax reflected a 1.9% increase in the total organisational tax rate, the true current tax dropped from 30.7% to 27.9% as a direct result of tax optimisations made.
As the organisation has a combined group revenue of greater than $100 million this financial year, the Company will be required to pay tax on its accrued unearned revenues from term deposits held which is reflected under current income taxes on the Statement of Profit or Loss and Other Comprehensive Income. This required tax treatment results in the accrued unearned revenues being paid on an accrual basis this year, instead of on a cash receipt basis next year effectively bringing forward this cash tax outflow.
Throughout the year, the Company has taken advantage of its scaled workforce, infrastructure, and capacity to drive the significant growth of revenues, assets and clinical programs. With the exception of a couple of areas within the business, the majority of scale has now reached its optimal level to support our current programs.
Balance Sheet Strength
Cash Reserves and Liquidity Position
During the financial year, our balance of cash reserves, comprising cash and cash equivalents and cash held in term deposits, increased by $40.2 million (22%) to $224.1 million compared to FY2024. This growth stemmed from both operational activity net inflows and the strategic decision to increase the average length of the Company’s term deposits to a weighted average return of 4.70% over an average term of 309 days. There were no cash inflows from debt or equity financing and for the 20th consecutive year that the Company has remained debt-free.
The returns from prudent liquidity management directly support operational expenditures as well as the extensive commercial, clinical, and pharmaceutical programs into new revenue streams.
Balance Sheet and Financial Strength
Maintaining a financially sound Balance Sheet remains of strategic importance to CLINUVEL. This is evidenced by a $39.7 million increase in total assets and just a $2.8 million increase in total liabilities, being trade and other payables, reflective of the significant increase in operational activities. CLINUVEL experienced a $36.9 million (18%) improved net asset position to $239.9 million and an improved debt-to-equity ratio from 13.8% in FY2024 down to 12.9% in FY2025 with no external sources of debt funding.
CLINUVEL’s Balance Sheet will not only permit the Company to continue exploring strategic M&A opportunities but also ensures the organisation can deliver on its strategic product development and clinical programs without being at the mercy of the markets as so many other biotechnology companies have been, particularly in the current times of geopolitical uncertainty.
This non-reliance on external funding to support operations protects, preserves long-term shareholder value avoiding the need for dilution at considerable discounts as is the familiar model of traditional biotechnology companies.
We are actively pursuing several strategic acquisitions and investments that align with growth and diversification objectives, and we anticipate being able to make some positive announcements about these developments in the coming period.